Suture-based orthopedic joint devices

ABSTRACT

Devices and treatments for various joint conditions include a resilient elongate orthopedic device inserted into a joint space using a suture. The suture is passed through the joint space and used to pull the orthopedic device into the joint space. The suture may be using a percutaneously inserted needle or other type of needle-based delivery instrument. The resilient elongate orthopedic device may be restrained to a reduced profile that permits minimally invasive implantation, but assume an enlarged profile when positioned at an implantation site.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation of U.S. application Ser. No.12/210,101, filed Sep. 12, 2008, which is hereby incorporated byreference in its entirety. This application is also related to U.S.application Ser. No. 12/210,099, filed Sep. 12, 2008, U.S. applicationSer. No. 12/099,296, filed Apr. 8, 2008, U.S. application Ser. No.11/862,095, filed Sep. 27, 2007, U.S. Provisional Ser. No. 60/911,056,filed Apr. 10, 2007, and U.S. Provisional Ser. No. 60/975,444, filedSep. 26, 2007, all of which are hereby incorporated by reference intheir entirety.

BACKGROUND OF THE INVENTION

Today, there are an increasing number of patients with osteoarthritis,rheumatoid arthritis, and other joint degenerative processes.Osteoarthritis is by far the most common type of arthritis, and thepercentage of people who have it grows higher with age. An estimated12.1 percent of the U.S. population (nearly 21 million Americans) age 25and older have osteoarthritis of one form or another. Although morecommon in older people, it usually is the result of a joint injury, ajoint malformation, or a genetic defect in joint cartilage. Theincidence and prevalence of osteoarthritis differs among variousdemographic groups: osteoarthritis tends to start for men before the ageof 45, and after the age of 45 it is more common in women. It is alsomore likely to occur in people who are obese or overweight and isrelated to those jobs that stress particular joints.

Arthritis is a degenerative process that affects the musculoskeletalsystem and specifically the joints—where two or more bones meet. Itoften occurs in the joints of the hands and wrists (particularly in thefingers and thumbs, between the phalanges, the metacarpals and/or thecarpals), feet (in the toes, between phalanges, metatarsals and/ortarsals), ankles, elbows, shoulders, knees, hips, and the spine(particularly at the neck and lower back). Joint problems can includeinflammation and damage to joint cartilage (the tough, smooth tissuethat covers the ends of the bones, enabling them to glide against oneanother) and surrounding structures. Such damage can lead to jointstiffness, weakness, instability and visible deformities that, dependingon the location of joint involvement, can interfere with the basic dailyactivities such as walking, climbing stairs, using a computer keyboard,cutting food and brushing teeth. This ultimately results in moderate tosevere pain. Drug regimes can provide temporary relief from the pain,but do not slow down the crippling affects. Drugs may also subjectpatients to serious side effects and risks, such as the increasedcardiovascular risks associated with osteoarthritis drugs Vioxx andBextra, which were withdrawn from the market. Drugs used to treat otherforms of arthritis, such as corticosteroids, are associated withosteoporosis and hyperglycemia and can lead to increased risks of bonefracture and diabetes, for example. When pharmacologic therapy andphysical therapy no longer provide adequate relief, only surgicaloptions remain.

The extreme result or end point in traditional treatments is an opensurgical procedure to implant a spacer or to perform total jointreplacement with a prosthetic device. Current joint replacementtherapies (spacers or a total prosthesis) require the joint capsule tobe surgically opened and the bone surfaces to be partially or totallyremoved. Both modalities present various drawbacks. For example, U.S.Pat. No. 6,007,580 to Lehto et al. describes an implantable spacer thatmust be fixed at one or both ends to the bone of either end of theknuckle (e.g. the metacarpal-phalangeal (MCP) joint). The spacer must beimplanted by opening of the joint capsule and be affixed at one or bothends to the corresponding bone surfaces.

Various spacers in the art can cause inflammation, while total jointreplacement can limit the range of motion and also compromise thestrength and stability of the joint. These surgeries are highly invasiveand require the joint capsule to be surgically opened, and the incisionitself can result in inflammation and infection. Due to the invasivenessof the procedure, prolonged healing times are required. Furthermore, theinvasive nature of these surgeries sometimes precludes a second jointreplacement or spacer when the first joint device wears out or fails.

It would be desirable as well as beneficial if there were anintermediary step or alternative treatment before subjecting patients todrastic joint replacement and/or long-term drug therapy.

BRIEF SUMMARY OF THE INVENTION

Various embodiments disclosed herein relate generally to the treatmentof osteoarthritis, rheumatoid arthritis, and other degenerative jointprocesses, and include but are not limited to minimally invasiveimplantable devices to reduce bone-to-bone contact in a joint.

Systems and methods for treating degenerative joint conditions includean orthopedic device comprising a resilient elongate member, which maybe implanted in a joint space using a suture or other type of bendableelongate element. Using minimally invasive surgical techniques, a smallskin incision and arthrotomy are made to provide access to the joint.The suture is passed through the incision and joint space and used topull the orthopedic device into the joint space. The suture may also beinserted using a percutaneously inserted needle or other type ofneedle-based delivery instrument. The orthopedic device may berestrained to a reduced profile that permits minimally invasiveimplantation, but changes to an enlarged profile when positioned at animplantation site. The orthopedic device may comprise a shape-memoryand/or superelastic material, and may comprise an open or closed shapeconfiguration.

In one example, an orthopedic joint device is provided, comprising aresilient C-shape joint device with a shape-memory elongate curved coreand an outer polymeric articular jacket, where the joint device has afirst configuration where the C-shape joint device is coupled to asuture and in a deformed reduced profile, a second configuration wherethe joint device is coupled to the suture and in an expanded profile,and a third expanded configuration where the joint device is in theexpanded profile without coupling to the suture.

In another example, an orthopedic device system comprises an orthopedicdevice with a resilient elongate core, a flexible polymeric jacketcovering at least a portion of the resilient elongate core, and a firstsuture aperture, wherein the orthopedic device is configured to residebetween two opposing articular surfaces and within a joint space of ajoint. In some further examples, the elongate core may have a deliveryconfiguration and an implantation configuration, and the implantationconfiguration is optionally a non-linear configuration, including butnot limited to a “C”-shape configuration. In other examples, thedelivery configuration may be a linear configuration. The first sutureaperture may comprise a suture lumen through the jacket, or a sutureeyelet coupled to the jacket, while in some examples, the core maycomprise a suture eyelet. In one specific example, the suture eyelet maycomprise a twisted loop of the core. Some systems may further comprise asuture, which may be located in the first suture aperture. In someexamples, the system may also further comprise a penetrating member,which is optionally pre-attached to the suture. The penetrating member,the suture and the orthopedic device may be provided in a single sterilepackage. The system may also further comprise a penetrating memberholder, which in turn may optionally comprise an orthopedic deviceretaining assembly, such as a retaining post. In some examples, theelongate core may have an elongate length that is at least about 50% ofthe circumference of the joint space. The joint space may be a jointspace of a carpo-metacarpal joint, such as the carpo-metacarpal joint ofa thumb. In some systems, the orthopedic device may further comprise aninner region at least partially surrounded by the resilient elongatecore, and at least one span member across the inner region. Sometimes,the span member may have a planar configuration, and may comprise aresilient or elastic material, for example. The jacket of the orthopedicdevice may comprise a thickened jacket region about the first sutureaperture. The system may also optionally comprise a first pull memberand a second pull member, wherein the first pull member is coupled tothe first suture aperture. The second pull member may be coupled to asecond suture aperture, and in some further examples, the first andsecond pull members may each pass through a third suture aperture. Anoptional third pull member may also be coupled to the third sutureaperture.

In another example, a method of implanting a orthopedic device in apatient is provided, comprising percutaneously inserting a needlethrough a first joint capsule opening of a joint space, passing theneedle with an attached suture across the joint space and through asecond joint capsule opening, wherein the second joint capsule openingis smaller than the first joint capsule opening, pulling a resilientorthopedic device into the joint space using the suture, wherein theresilient orthopedic device comprises a first end, a second end, and abody therebetween having an elongate arcuate configuration, separatingat least a portion of the suture from the resilient orthopedic device,and removing at least a portion of the suture from the patient. Themethod may optionally further comprise abutting the resilient orthopedicdevice against the second joint capsule opening, positioning theresilient orthopedic device symmetrically within the joint space withrespect to the second joint capsule opening, and/or restraining theresilient orthopedic device in a reduced profile as the resilientorthopedic device traverses the first joint capsule opening. In somefurther examples, the method may further comprise enlarging theresilient orthopedic device from a reduced profile to an enlargedprofile with substantially the same volume as the orthopedic device inthe reduced profile, and/or with substantially the same mass as theorthopedic device in the reduced profile. The method may also furthercomprise restraining the resilient orthopedic device in a deliveryconfiguration as the resilient orthopedic device traverses the firstjoint capsule opening. The method may also further comprise releasingthe resilient orthopedic device from the delivery configuration in thejoint space to assume an implantation configuration that is non-linear.In some methods, a distance between a first end and a second end of theresilient orthopedic device in the delivery configuration is greaterthan the distance between the first end and the second end of theresilient orthopedic device in the implantation configuration. Theimplantation configuration may comprise at least one arcuate section,and/or a generally a non-planar implantation configuration. In someexamples, a first portion of the resilient orthopedic device may have adelivery position in the delivery configuration that is different froman implantation position in the implantation position with respect to asecond portion of the resilient joint implant. The method may alsofurther comprise orienting the resilient orthopedic device in the jointspace such that the delivery position and the implantation position ofthe first portion of the resilient orthopedic device generally lie in aplane that is generally aligned with an axis between the first andsecond joint capsule openings. In some examples, the resilientorthopedic device may be pre-coupled to the suture at thepoint-of-manufacture. Also, when pulling the resilient orthopedicdevice, the pulling may be performed such that the body of the resilientorthopedic device enters the joint space before the first and secondends. The joint space may be a trapeziometacarpal or a carpo-metacarpaljoint, for example, and the first joint capsule opening may be locatedon the dorsal surface of the joint space.

In another embodiment, the method of implanting a orthopedic device isprovided, comprising pulling a joint implant into a joint space from afirst joint capsule opening using a pulling force acting through asecond joint capsule opening. The joint space may be located in anextremity of a patient, including the upper extremities and the lowerextremities, and the joint space may be a carpal-metacarpal joint space,for example. The second joint capsule opening may be formed using apenetrating member, which may be formed from the joint space or externalto the joint space. Examples of the penetrating member may include aneedle attached to a suture, and the method may further comprise passingthe suture through the first joint capsule opening and through thesecond joint capsule opening. The method may also further comprisecoupling the suture and the joint implant together, such as passing thesuture through the joint implant, or passing the suture through apre-formed lumen of the joint implant, or looping the suture around thejoint implant. The joint implant may be a bendable joint implant havinga reduced profile and an enlarged profile, wherein the enlarged profilehas substantially the same volume and/or mass as the reduced profile. Insome examples, the joint implant may comprise at least one articulatedjoint, such as a plurality of pivot joints. In other examples, the jointimplant may be a resilient joint implant. While passing through thefirst joint capsule opening, the resilient joint implant may be in arestrained configuration, and in some instances, the resilient jointimplant may be placed in the restrained configuration at thepoint-of-manufacture or at the point-of-use. A delivery cannula may beused to restrain the resilient joint implant. The method may alsooptionally comprise positioning the delivery cannula in the joint spacethrough the first joint capsule opening. In some instances, the pullingforce acts through a flexible line coupled to the joint implant, andsometimes, any tension in the flexible line may be relieved after thejoint implant is located in the joint space. The method may alsocomprise separating at least a portion of the flexible line from thejoint implant and pulling at least a portion of the flexible line out ofthe joint space.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features will now be described in connection withvarious embodiments herein, in reference to the accompanying drawings.The illustrated embodiments, however, are merely examples and are notintended to limit the claimed subject matter.

FIG. 1A is a schematic top view of one embodiment of an orthopedicdevice comprising a substantially straightened configuration.

FIG. 1B is a schematic top view of one embodiment of an orthopedicdevice comprising an open hoop arcuate configuration.

FIG. 1C is a schematic top view of one embodiment of an orthopedicdevice comprising a nautilus-style spiral arcuate configuration.

FIG. 1D is a schematic top view of one embodiment of an orthopedicdevice comprising a closed polygonal configuration.

FIG. 1E is a schematic top view of the orthopedic device of FIG. 1D in acollapsed delivery configuration.

FIG. 1F is a schematic top view of one embodiment of an orthopedicdevice comprising a closed circular configuration.

FIG. 1G is a schematic top view of the orthopedic device of FIG. 1F in acollapsed delivery configuration.

FIG. 2 is a schematic cross-sectional view perpendicular to alongitudinal axis of an embodiment of an orthopedic device comprising anelongate core and an articular layer surrounding at least a portion ofthe core.

FIG. 3A is a schematic longitudinal cross-sectional view of anembodiment of an orthopedic device having a substantially straightenedconfiguration and comprising an elongate core and an articular layersurrounding at least a portion of the core.

FIG. 3B is a schematic longitudinal cross-sectional view of anembodiment of an orthopedic device having an open hoop arcuateconfiguration, the device comprising an elongate core and an articularlayer surrounding at least a portion of the core.

FIG. 3C is a schematic cross-sectional view of an embodiment of anorthopedic device having a nautilus-style spiral arcuate configuration,the device comprising an elongate core and an articular layersurrounding at least a portion of the core.

FIG. 3D is a schematic longitudinal cross-sectional view of anembodiment of an orthopedic device having an open hoop arcuateconfiguration, the device comprising one or more elongate cores wrapped,braided or folded along a length of the device and an articular layersurrounding at least a portion of the core.

FIG. 3E is a schematic longitudinal cross-sectional view of anembodiment of an orthopedic device having a nautilus-style spiralarcuate configuration, the device comprising one or more elongate coreswrapped, braided or folded along a length of the device and an articularlayer surrounding at least a portion of the core.

FIG. 3F is a schematic planar cross-sectional view of the orthopedicdevice of FIG. 1F.

FIG. 3G is a schematic planar cross-sectional view of the orthopedicdevice of FIG. 1G.

FIG. 4A is a schematic side view of an embodiment of an elongate corecomprising one or more substantially linear or straight members.

FIG. 4B is a schematic side view of an embodiment of an elongate corecomprising one or more wave, curve or zig-zag members disposed in one ormore planes.

FIG. 4C is a schematic side view of an embodiment of an elongate corecomprising one or more members in a braided or weave configuration.

FIG. 5A is a schematic top view of an embodiment of an elongate corecomprising an open hoop arcuate configuration and one or more endpieces.

FIG. 5B is a schematic top view of an embodiment of an elongate corecomprising an open hoop arcuate configuration and one or more bends orhooks.

FIG. 5C is a schematic top view of an embodiment of an elongate corecomprising an open hoop arcuate configuration and one or more featuresbent in or out of the primary plane of the device.

FIG. 5D is a schematic side view of an embodiment of an orthopedicdevice comprising a multi-planar spiral configuration.

FIG. 5E is a schematic side view of an embodiment of an orthopedicdevice comprising a multi-planar arcuate configuration.

FIG. 5F is a schematic side view of an embodiment of an orthopedicdevice comprising a “W”-shape configuration.

FIGS. 6A to 6K are schematic cross-sectional views of variousembodiments of elongate cores.

FIGS. 6L to 6S are schematic superior and cross-sectional views ofvarious embodiments of orthopedic devices with non-circularcross-sectional shapes.

FIGS. 6T to 6W are schematic superior and cross-sectional views ofvarious embodiments of an orthopedic device with a membrane member.

FIG. 6X is a schematic superior view of additional embodiment oforthopedic device with membrane member.

FIG. 6Y is a schematic superior view of an embodiment of an orthopedicdevice comprising a textured surface.

FIG. 6Z is a schematic superior view of an embodiment of an orthopedicdevice comprising one or more retaining structures.

FIG. 7A is a schematic perspective view of an embodiment of anorthopedic device comprising a plurality of independent orinter-connectable discrete elongate members.

FIG. 7B is a schematic perspective view of an embodiment of anorthopedic device comprising a plurality of independent orinter-connectable discrete elongate members in a “W”-shapeconfiguration.

FIG. 8 is a schematic perspective view of an embodiment of an orthopedicdevice comprising a plurality of independent or inter-connectablediscrete members.

FIG. 9A is a schematic side view of an embodiment of an elongate corecomprising a plurality of inter-connectable discrete members in asubstantially straightened configuration.

FIG. 9B is a schematic side view of an inter-connectable discrete memberof FIG. 9A.

FIG. 9C is a schematic side view of an embodiment of an elongate corecomprising a plurality of inter-connectable discrete members accordingto FIG. 9A in an arcuate open loop configuration.

FIGS. 10A to 10L are schematic cross-sectional views of one embodimentfor implanting an orthopedic device in a joint space using a suture.FIGS. 10A, 10C, 10E, 10G, 101 and 10K are longitudinal cross-sectionalviews through the joint, whereas FIGS. 10B, 10D, 10F, and 10H, 10J and10L are the corresponding axial cross-sectional views, respectively.

FIG. 11 is a schematic representation of an embodiment of a penetratingmember.

FIGS. 12A and 12B are schematic representations of various embodimentsof penetrating sections of penetrating members.

FIGS. 13A to 13C are schematic representations of various embodiments ofsuture coupling structures of penetrating members.

FIG. 14 is a schematic representation of a suture-based penetratingmember.

FIG. 15 is a superior elevational view of an embodiment of an orthopedicdevice.

FIGS. 16A and 16B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 16C and 16D are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 17A and 17B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 18A and 18B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIG. 18C is a schematic representation of a suture-based sling; FIG. 18Ddepicts the sling of FIG. 18C looped around an orthopedic device.

FIGS. 19A and 19B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 19C to 19E are schematic superior elevational views of otherembodiments of orthopedic devices.

FIGS. 20A and 20B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 21A and 21B are schematic superior elevational and sidecross-sectional views of another embodiment of an orthopedic device.

FIGS. 22A and 22B depict various embodiments of an orthopedic devicewith multiple sutures.

FIGS. 23A and 23B depicts another embodiment of a user-adjustableorthopedic device with multiple sutures, before and after adjustment;FIGS. 23C and 23D depict another embodiment of a user-adjustableorthopedic device, before and after suture fixation; FIGS. 23E and 23Fdepict another embodiment of a user-adjustable orthopedic device, beforeand after locking.

FIG. 24 depicts one embodiment of an orthopedic device coupled to aneedle using a suture.

FIGS. 25A and 25B are superior and anterior elevational views of oneembodiment of a needle driver.

FIG. 26 is a superior elevational view of the needle driver of FIG. 25Aloaded with the orthopedic device of FIG. 24.

FIG. 27 is a superior elevational view of the needle driver of FIG. 25Aloaded with an embodiment of an orthopedic device with a coiled suture.

FIGS. 28A and 28B are superior elevational and side cross-sectionalviews of another embodiment of a needle driver with a flanged mount andloaded with the orthopedic device of FIG. 24.

FIG. 29 is a side elevational view of the needle driver in FIG. 28Aloaded with the orthopedic device of FIG. 27.

FIGS. 30A, 31A and 32A are schematic side cutaway views depicting theuse of the system in FIG. 28A in a joint, whereas FIGS. 30B, 31B and 32Bare the corresponding superior cutaway views, respectively.

Throughout the figures, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components or portions of the illustrated embodiments. In certaininstances, similar reference number schemes are used whereby thereference numerals referred to as “AA” in reference numeral “AAxx”correspond to a figure while the “xx” is directed to similar orinterchangeable features, elements, components or portions of theillustrated embodiments in different figures. In certain instances,similar names may be used to describe similar components with differentreference numerals which have certain common or similar features.Moreover, while the subject invention will now be described in detailwith reference to the figures, it is done so in connection with theillustrative embodiments. It is intended that changes and modificationscan be made to the described embodiments without departing from the truescope and spirit of the subject invention as defined by the claims.

DETAILED DESCRIPTION OF THE INVENTION

As should be understood in view of the following detailed description,this application is generally directed to systems and methods forminimally-invasive treatment of bone joints, in both medical andveterinary settings (including both small and large animal veterinarymedicine). Bone joints contemplated for various embodiments of theorthopedic systems and methods include, but are not limited to, hands(fingers and thumbs, between phalanges, metacarpals and/or carpals),feet (in the toes, between phalanges, metatarsals and/or tarsals),wrists, elbows, shoulders, knees, hips, and the spine (particularly atthe neck and lower back). In some embodiments, an orthopedic devicecomprises a shape memory body that is inserted into the joint space,which may restore proper joint alignment and joint mobility affected bydegenerative processes. In some embodiments, the orthopedic device has agenerally arcuate or rectilinear configuration, which may enhanceself-centering positioning of the orthopedic device when deployed.

Referring to FIG. 1A, in one embodiment, the orthopedic device 100 acomprises a resilient or flexible elongate body 105 with a proximal end110 a and a distal end 120 a, and adapted to undergo configurationalchange. For example, the elongate body 105 of orthopedic device 100 amay have a straight configuration as depicted in FIG. 1A, but may alsohave, for example, an arcuate “C”-shape configuration as shown in FIG.1B, and/or a spiral-shape configuration in FIG. 1C. The change from oneconfiguration to another may, for example, facilitate implantation ofthe orthopedic device in a minimally invasive manner, and/or facilitateforce redistribution in the joint during movement or positioning.

In one particular embodiment, the distal end 120 a of the orthopedicdevice 100 a may be advanced or inserted into the body of a patientfirst, before the proximal end 110 a of the orthopedic device 100 a isinserted. In some embodiments, the orthopedic device 100 a has a shapeor configuration that facilitates its loading into a lumen within aneedle, cannula, or other device for delivering the orthopedic device tothe implantation site. The straightened configuration of orthopedicdevice 100 a may be used for delivery of the orthopedic device 100 afrom a substantially straight needle. As the device 100 a exits theneedle or cannula, the configuration of the device 100 a may change toassume the arcuate or spiral configurations of FIGS. 1B and 1C. Inanother example, the elongate body 105 of the orthopedic device 100 amay be bent or biased to a curve to permit delivery from curved or othernon-linear needles or cannulae. Thus, the orthopedic device need nothave a linear delivery configuration as depicted in FIG. 1A. Theorthopedic device 100 a may also be configured with a lumen or one ormore apertures to facilitate delivery over a delivery structure, such asa rigid or flexible guidewire. Once implanted into the joint, theorthopedic device may be configured to re-expand to its pre-deliveryconfiguration, or may expand to a different configuration. Thedeployment configuration may be different, depending upon the baseconfiguration of the orthopedic device, and/or whether the orthopedicdevice has a resilience or bias to one or more particularconfigurations. The resulting configuration may also result fromanatomical restrictions, for example, relating to the dimensions of thejoint capsule, or the geometry of the articular surface. The deploymentconfiguration in the joint capsule may vary in use, depending upon thejoint position, the body position of the patient (e.g. standing or lyingdown) and other conditions which may alter the forces acting on thejoint and the orthopedic device. In one example, an orthopedic devicehas an arcuate configuration that is less-curved, or has a larger majordiameter, than the device as fully deployed in the joint, or has anenlarged configuration with at least one dimension that is larger thanthe corresponding joint space dimension when deployed in the jointspace.

In one embodiment, the orthopedic device may be configured and implantedto permit its displacement and/or deformation within the joint. In someinstances, the movement and/or deformation facilitates the conformationof the orthopedic device to the natural movement of the bones throughthe range of motion of the joint. For example, the orthopedic device maybe implanted into a joint without any attachment to adjacent tissue andconstrained only by the joint capsule and/or ligaments within the joint.In some examples, because the device is not fixed in place (e.g.attached to either end of bones in a joint), the device may “float”between the ends of the bones in a joint. In some embodiments, afloating design and implantation procedure may provide a mechanicaladvantage over that of a fixed-type orthopedic device that is rigidlyattached to bone tissue by redistributing forces acting on the joint.

For example, the “open ring,” “hoop” or “coil” configuration, or any“open” embodiment, including open polygons of an orthopedic device, maypermit a greater range of deformation than closed structures. An opendesign may facilitate the distribution of the loading, shearing and/orcompressive forces seen by the articulation and/or loading of the joint.Thus, in certain open embodiments of orthopedic devices that areflexible, such as orthopedic device 100 b, the open configuration mayoffer reduced or minimal resistance to shape change. Thus, theorthopedic device 100 b can spring open or closed as force is applied tothe device or to the joint, but still maintain a bearing, cushion,slidable, or articulate surface. However, orthopedic devices with aclosed configuration may also be used and may also have deformationproperties.

In some embodiments, the gap between the proximal and distal ends of anorthopedic device with an open configuration could be extended to theentire length of the orthopedic device, e.g. when a device is completelystraightened. However, various embodiments of an orthopedic device maybe configured with functional operating ranges allow varying degrees offlexion and gap widening to support loads and articulation in the joint.In some embodiments, the functional operating range is based upon theamount of stress and strain that the orthopedic device can undergowithout significant plastic change (e.g. less than 5%). In someembodiments comprising a shape memory material such as nickel-titanium,the functional operating range may lie within the range of pseudoelasticdeformation of the shape memory component, e.g. a Nitinol core that canundergo strain up to about 8%. In one embodiment, the functional flexionin an open orthopedic device allows for a change in the gap between theopen ends of the orthopedic device in situ to flex in a range from about0.5 to about 6 times or more the distance between the gap when theorthopedic device is in its natural state, either pre-implantation or insitu. In one embodiment, the deformation or flex range is roughly fromabout 2 to about 6 times or greater the natural gap distance, and inanother embodiment the flex range is about 3 to about 5 times greater.In one example, the orthopedic device has a flex range with an upperlimit of about 4 times. In one embodiment the functional gap can be aswide as a first dimension, diameter, or width of the over all orthopedicdevice. Thus, orthopedic device 100 b may allow for the redistributionof the compressive and/or shearing forces, as well as the resulting wearalong the device. In certain embodiments, the orthopedic devicescomprise arcuate configurations, such as an open circle or continuousspiral configurations, rather than closed configurations like a completering or closed circular shape. The open configurations may result inincreased dissipation or redistribution of loading and compressionforces though at least one or two deformations in the orthopedic device.First, an open ring may allow for dynamic loading response as force thatis applied to the joint is partially dissipated by the force necessaryto radially-outwardly deform the open ring or spiral into a largerradius profile. In one embodiment, the operating range of radialdeformation of an arcuate orthopedic device is in the range of about 0to about 50% of the orthopedic device profile diameter within the joint.Second, as discussed above, the compression of the articular layer mayresult in cross-sectional deformation into a flatter shape, which mayalso dissipate force or pressure in the joint.

In one embodiment, the orthopedic device 100 b is sized to snugly fitinto the joint capsule itself. In some specific embodiments, one or moreportions of the orthopedic device may be sized and/or configured toconform to the dimensions of the joint capsule. This fit may facilitatethe seating or centering of the orthopedic device 100 b with respect tothe axis of the bones of the joint, such as in a proximal or distalinterphalangeal (PIP/DIP) joint of a finger or an MCP joint of aknuckle.

As used herein, “arcuate” may refer to curved or rounded configurationsor shapes, but can also include generally arcuate configurations andshapes that have some straight aspect or element with curved or roundedconfigurations or shapes. As used herein, arcuate and generally arcuateshapes can include open or closed “C”, “O”, “S”, spiral, nautilus, “Q”and other generally arcuate shapes which can be planar or non-planar.Certain embodiments of the orthopedic device may have open or closedrectilinear configurations, which can include polygons such astriangles, squares, rectangles, diamonds, rhombuses, pentagons,hexagons, octagons and other shapes with generally straight edges, andfurther including shapes and configurations that are generallyrectilinear having some curved edge or corners or segments amongrectilinear shapes. As used herein, rectilinear and generallyrectilinear shapes can include “N”, “M”, “W”, “Z”, “T”, “Y”, “V”, “L”,“X” and other generally rectilinear shapes. FIG. 5F, for example,depicts an embodiment of a rectilinear orthopedic device 570 f,comprising a “W”-shape configuration. Various embodiments of generallyarcuate or generally rectilinear shapes can include shapes with bothrectilinear and arcuate portions, such as a “P”, “R”, “B”, and “U”.

Embodiments of the orthopedic device may have three major dimensions,which can correspond to a first major dimension, a second majordimension and a third major dimension. In one embodiment, the firstmajor dimension, second major dimension and third major dimensioncorrespond to a width, a height and a thickness, respectively. Certainembodiments have a thickness which corresponds to the smallestdimension, which may generally correspond to the spacing betweenarticulating surfaces of tissue such as bone or cartilage in a joint. Inone embodiment, the width and height can be the same, such as with acircular or square-shape orthopedic device. In other embodiments, theheight and width may be different, as with an oval shape or a rectangleor other shape with non-equal height and width. In some embodiments, theorthopedic implant can be implanted in joints of varying sizes, in whichthe first major dimension and second major dimension may have a range ofabout 0.0394 to about 4.0 inches (or about 1.0 to about 101.6 mm) andthe third major diameter may have a range of roughly about 0.001 toabout 0.50 inches (or about 0.025 to about 15 mm). Orthopedic deviceshaving other dimensions may also be used, including but not limited toorthopedic devices configured for larger joints such as the knee, hip,ankle, and shoulder, for example. Although the orthopedic device may beimplanted between the articular surfaces of two bones, the articularsurfaces are not limited to the hinge joints and may include slidingjoints. In some examples, the orthopedic device may be inserted intovarious joints and other locations of the spine, including the facetjoints, in an intervertebral disc, or in the post-discectomy spacebetween the endplates of two adjacent vertebral bodies.

As mentioned previously, certain embodiments of the orthopedic devicemay have a narrowed configuration or a reduced profile to fit in a lumenof a delivery tube or delivery device, or through a small opening in ajoint capsule. In one embodiment, a narrowed configuration comprises thereduction of the first major dimension, second major dimension or thirdmajor dimension, or a combination thereof. In some embodiments withnarrowing configurations, one or more dimensions are reduced while oneor more other dimensions are increased. In one embodiment, theorthopedic device can be moved into a narrowed configuration bypinching, squeezing or restraining the device so that parts of theorthopedic device overlap, such as a “C”-shape body being collapsed intoan alpha shape (α), a gamma shape (γ), a twisted shape, a helix, and/ora multi-planar configuration, as illustrated in the embodiments of FIGS.5D and 5E, for example. In one embodiment, the orthopedic device may bemanipulated into a straightened or a substantially straightenedconfiguration. In one embodiment, the orthopedic device may have asubstantially straightened configuration, including a completelystraightened, linear configuration, as well as configurations in whichat least a part of the orthopedic device is straightened or partiallystraightened, configurations in which arcuate orthopedic devices can bemade less-arcuate and configurations in which rectilinear orthopedicdevices can be made less-rectilinear.

Referring back to FIG. 1A, some embodiments of the orthopedic device mayhave a relatively uniform width or diameter along its elongate length.However, in other contemplated embodiments, the width of the device bodycan vary along its length. For example, some orthopedic devices may haveone or more tapered sections along a portion of its length, or betapered along the device's entire length. The tapered section may have alinear or a non-linear taper configuration, and embodiments with two ormore tapered sections need not taper in the same direction. The width,or other dimensions of the orthopedic device, can vary from large tosmall or small to large, making the device thicker in some portions thanin others. In one embodiment, the device may be radially compressiblealong part or over the entire length of the device. In one embodiment,the device may be compressed such that its cross-sectional area isreduced, so that the device may exit a delivery system and expand to alarger cross-sectional area. In one embodiment, the device can beaxially compressed or axially stretched along part or over the entirelength of the device.

In one embodiment, the orthopedic device 100 a comprises a shape memorymaterial. For example, the shape memory material can be made from ashape-memory material, such as Nitinol, or a shape memory plastic,polymeric, or synthetic material, such as polycarbonate urethane. Oneexample of this type of a polyurethane or polyurethane-urea polymershape memory material is described in United States Patent Publication2002/0161114 A1, which is hereby incorporated by reference in itsentirety and which describes a shape memory polyurethane orpolyurethane-urea polymer including a reaction product of: (A) (a)silicon-based macrodiol, silicon-based macrodiamine and/or polyether ofthe formula (I): A-[(CH2)m-O-]n-(CH2)m-A′, wherein A and A areendcapping groups; m is an integer of 6 or more; and n is an integer of1 or greater; (b) a diisocyanate; and (c) a chain extender; or (B) (b) adiisocyanate: and (c) a chain extender, where the polymer has a glasstransition temperature which enables the polymer to be formed into afirst shape at a temperature higher than the glass transitiontemperature, and where the polymer is maintained in the first shape whenthe polymer is cooled to a temperature lower than the glass transitiontemperature, so that the polymer is capable of resuming its originalshape on heating to a temperature higher than the glass transitiontemperature. Various embodiments may include a shape memory polymeralone, or a blend of two or more of the shape memory polyurethane orpolyurethane-urea polymers or at least one shape memory polyurethane orpolyurethane-urea polymer defined above in combination with anothermaterial. Other embodiments relate to processes for preparing materialshaving improved mechanical properties, clarity, processability,biostability and/or degradation resistance and devices or articlescontaining the shape memory polyurethane or polyurethane-urea polymerand/or composition defined above.

In other embodiments, the orthopedic device may comprise any of avariety of rigid, semi-rigid or flexible materials, which may bemetallic or non-metallic, polymeric or non-polymeric, bioresorbable ornon-bioresorbable, lipophilic, hydrophilic or hydrophobic, for example.These materials may include but are not limited to stainless steel,cobalt-chromium, titanium, pyrolytic carbon, any of a variety of ceramicor hydroxyapatite-based materials, polymers such as PTFE, silicone,nylon, polyethylene, polypropylene, polycarbonate, polyimide,polycarbonate, polyurethane, PEEK, PEKK and PEBAX, any of a variety ofbioresorbable materials such as PGA, PLA, PLGA, PDS and the like, aswell as chitosan, collagen, wax and alginate-based materials, andanimal-derived materials such as small intestine submucosa (SIS).

In one embodiment, the orthopedic device 100 a comprises an articularlayer 105, blanket or jacket. The articular layer 105 is sized andconfigured to be placed within a body, such as in a joint, as a layerbetween bones of the joint to provide a slidable articulation surfaceand/or a cushion. In some embodiments, the articular layer can rangefrom about 0.001 to about 0.5 inches thick (or about 0.025 to about 13mm). The orthopedic device may or may not include a core, backbone orother support structure, which may support the articular layer orcontribute or impart certain features or characteristics to theorthopedic device. Support structures, such as the core, are describedin greater detail below.

In one embodiment, the articular layer 105 is configured to becompressed by forces acting on the joint. For example, in one embodimentan articular layer may be compressed from a substantially circularcross-sectional shape to an oval, elliptical, or football shapedcross-sectional shape. As the compression occurs, the amount of surfacecoverage of the articular layer with respect to bony joint contact,resulting in reduced in relative pressure across the joint. In oneembodiment, the operating range of compression of an orthopedic deviceis in the range of about 0 to about 50% of the cross-sectional diameteror other dimension along the axis of compressive force.

The articular layer 105 may comprise one or more layers of material, andany of a variety of materials may be used for each layer. In certainembodiments of the orthopedic device 100 a, the body of the orthopedicdevice 100 a comprises an articular layer with shape-memory properties,with or without any backbone or other type of support structure. Theshape-memory properties may include but are not limited totemperature-induced configuration changes as well as stress-inducedpseudoelastic properties. In certain embodiments, the articular layer105 materials may include but are not limited to silicone, PTFE orePTFE, ultra high molecular weight polyurethane or and any implantablegrade material, or other materials disclosed above. The articular layer105 can be compliant and/or compressible, or may have a non-compressibleconstruction. In certain embodiments, the articular layer 105 can haveany of a variety of durometers (material hardness) from about 30 toabout 90 Shore A, for example. In certain embodiments, the articularlayer 105 may comprise a porous material, which may have a closed oropen-pore structure. The porous coatings, layers or structures mayinclude but are not limited to macroporous or nanoporous coatings orstructures. In some instances, a porous coating may facilitate tissueingrowth and/or augment the inflammatory response to the orthopedicdevice, if any. In another embodiment, the coating material can form acasing (or covering) that is spongy or harder or less compliant. Thepores of the material could be loaded with one or more therapeuticagents. The casing could form a scaffold for tissue ingrowth and couldbe used in joints with certain wear characteristics, but is not limitedto use with these joints. In some embodiments, the articular layer 105may be coated with a secondary surface layer, such as another polymer ofa different material property, or an anti-friction high wear materialsuch as Parylene, or other similar materials which are known to the artas providing for a low friction surface.

In certain embodiments, the articular layer 105 may contain a materialor a drug to inhibit or promote inflammation, joint deterioration etc.,or a material or drug to encourage tissue regeneration or deviceencapsulation. For example, certain embodiments of the articular layer105 may be coated with or contain one or more therapeutic agents, suchas a long-acting steroid or a disease-modifying anti-rheumatic drug(DMARD). DMARDs include but are not limited to agents such as gold,D-penicillamine, methotrexate, azathioprine and cyclophosphamide,leflunomide, etanercept, infliximab, minocycline and certainanti-malarial agents used for arthritis treatment, for example. Thetherapeutic agents need not be limited to joint-specific therapy agents,however. In other embodiments, the therapeutic agent may include anantibiotic (e.g. a macrolide, a cephalosporin, a quinolone, anaminoglycoside, a beta-lactam or beta-lactamase inhibitor, alincosamide, or glycopeptides antibiotic, etc.), a sclerosing agent(e.g. bleomycin, tetracycline, talc, alcohol, sodium tetradecyl sulfate,etc.), or other type of inflammation-inducing agent, a growth factor(e.g. connective tissue growth factor, cartilage-derived retinoic acidsensitive protein), and other agents. In some embodiments, one or moretherapeutic agents may be injected or infused into a joint space,separate from the orthopedic device, using any of a variety of forms(aqueous solution, suspension, oil, foam, a separate drug eluting discor other structure, etc.). These therapeutic agents may includeviscosupplements (e.g. hylan G-F 20 such as Synvisc®, or variousformulations of sodium hyaluronate such as Hyalgan®, Suppartz®,Euflexxa® and Orthovisc®).

In other embodiments, the articular layer may comprise a plurality ofsurface projections and/or pores, which may cause a mechanical irritantresponse when implanted and may induce the growth of new tissue orcartilage, or an organization of fluids contained in the joint. Theprojections and/or pores may be grossly visible on the surface of thearticular layer, or may be nano- or micro-sized structures. Theprojections may comprise discrete surface structures or aggregatedstructures, including but not limited to hooks, barbs, tubes, rods,cones, spheres, cylinders, loops, pyramids, or a mix thereof. Thesestructures may have a size in the range of about 5 nm to about 5 mm ormore, sometimes about 50 nm to about 3 mm, and other times about 500 nmto about 1 mm, and in still other times about 1 μm to about 500 μm.

In one embodiment the coating and or covering can be used to stimulate athrombotic or coagulant response, and/or organization of tissues orfluids it contacts. For example, the coating or covering may comprise ahemostatic agent such as chitosan, zeolite, fibrinogen, anhydrousaluminum sulfate, titanium oxide, one or more clotting factors or otherconstituents of the blood clotting cascade.

In some embodiments, one or more therapeutic agents may be mixed with apolymer material which may either biodegradable or non-biodegradable.Thus, release of the therapeutic agents may occur by elution from thepolymer material, and/or by degradation of the polymer material. Forexample, an orthopedic device may comprise a material or reservoir beingdrug loaded and dissolvable through features provided in a jacketing orcoating material, such as through micro holes, pores, or some otherfeature. In certain embodiments the articular layer is provided withreservoirs, depots, cavities, wells, pockets, porous materials, bubblesor capsules for drug delivery. In one specific example, the orthopedicdevice could be a drug-loaded element that slowly dissolves to elute adrug of some sort through a casing that is spongiform or porous. Thiswould leave behind the casing after the ring has dissolved. In someembodiments, timed drug delivery could be configured for morecontrollable dosing. For example, about 75% to about 90% of atherapeutic agent may be released or dissolved over a timeframe ofanywhere from about 4 hours to about 4 months or more, sometimes fromabout 24 hours to about 6 weeks or more, other times from about 72 hoursto about 4 weeks, and still other times from about 2 weeks to about 4weeks. In other embodiments, the casing would maintain the space fillingor cushioning feature desired and/or allow for tissue organization orin-growth.

The therapeutic agent may be provided on an outer surface or an innersurface of the articular layer, or within a volume or layer of thearticular layer. As mentioned previously, the articular layer maycomprise one or more rate control layers to alter the rate oftherapeutic agent release. The rate control layer may comprise, forexample, polymer layers with a reduced permeability or smaller porestructure.

In one specific embodiment, a coating may comprise a xenograft,allograft or autograft biological covering, from a live and/or cadavericdonor, or a biological material grown from a tissue culture. Forexample, tissue harvested directly from the patient could be harvestedusing a laparoscope or other tissue removal and collection system andthen affixed to the core, articular layer, preshaped ring or backboneand secured to the orthopedic device. The tissue may include but is notlimited to omental tissue, ligamentous or tendinous tissue, cartilagetissue, bone tissue and the like. The graft material may retain thenative tissue structure or may have undergone additional mechanicalprocessing (e.g. crushing, blending, etc.) or biological processing(treatment with glutaraldehyde or other cross-linking agents,sterilization with electron-beam, gamma irradiation or ethylene oxide,etc.) The device could then be loaded into a delivery cannula andinserted and ejected (deployed) in the same fashion as the deliverysystems employed and described herein. In some embodiments, thearticular layer 105 comprises a cartilage replacement material, or anatural or synthetic cartilage.

In another embodiment, an orthopedic device is covered with a material,biological agent, or other coating that expands in volume with contactto fluids. The fluids may be the endogenous fluid found in the jointitself, and/or externally added fluids. Expandable materials may permitthe insertion of a device of a diameter that is smaller than the fullyexpanded finished diameter. For example, a coating on the backbone orthe articular layer could be hydrophilic in that it could transitionfrom one configuration or diameter (small for insertion) to a largerconfiguration or diameter when contacting either the body fluid or somefluid provided from an outside source, such as saline.

In one specific embodiment, the expandable or swellable covering maycomprise a composite or matrix with a polymer and a biological materiali.e. tissue, including but not limited to cartilage, collagen,ligaments, muscle, etc. In one embodiment, the scaffold could be apolymer-based material. In various embodiments, the casing or coveringof the orthopedic device is configured to swell from the small insertiondimension or diameter after implantation to a larger finished dimensionor diameter. In some alternate embodiments, such as those disclosed inU.S. application Ser. No. 12/099,296, filed Apr. 8, 2008, the orthopedicdevice may comprise an inflatable structure. The inflatable structuremay be inflated with a gas, liquid, gel, or slurry which may or may notbe curable to a solid state. The inflatable structure may also beexpanded by filling the structure with a volume of solid structures,such as microspheres or other small structures.

In certain embodiments, the articular layer 105 is radiopaque, and canaugment the visibility of the device when implanted as viewed by X-rayand/or fluoroscopic equipment. In one embodiment, the radiopacity of thearticular layer 105 is provided by radiopaque markers or structures (notshown here) on or embedded in the layer 105, or by loading or doping thearticular layer 105 with platinum, gold or other biocompatible metal.

In various embodiments, any of the features of the articular layer orcoatings mentioned herein may be combined on the orthopedic device,either as different layers of the orthopedic device or as differentsections or regions of the orthopedics device. In one embodiment, anarticular layer or coating can provide for tissue ingrowth or fusionwith bone, cartilage, or other tissue while another surface provides alow-friction surface to another side of the joint. Any combinations arepossible. In some embodiments, adhesives or transitional polymer layersmay be provided to facilitate the attachment of two or more other layersof the articular layer.

As described previously, the orthopedic device can have an arcuate,rectilinear or non-straightened configuration once it is implanted in ajoint. Some non-limiting examples of arcuate configurations include anopen ring (also called an open hoop or an open loop) such as is shown inthe embodiment in FIG. 1B, and a nautilus-style spiral as is shown inthe embodiment in FIG. 1C. Referring to FIG. 1B, the open hoop arcuateconfiguration of the orthopedic device 100 b has a proximal end 110 band a distal end 120 b in relation to insertion into the body of apatient, such as into a joint. In certain embodiments, the orthopedicdevice 100 b of FIG. 1B may have similar attributes and characteristicsof the orthopedic device 100 a of FIG. 1A, such as shape memory and/oran articular surface 105. In certain embodiments, orthopedic device 100b is an arcuate configuration of orthopedic device 100 a. In certainembodiments, the orthopedic device 100 a is biased to the configurationas shown for orthopedic device 100 b. The bias may be a preferredconfiguration for a flexible, pliable, bendable device. In certainembodiments, the orthopedic device of 100 a may change to from oneconfiguration to another (e.g. from the configuration of orthopedicdevice 100 a in FIG. 1A to the configuration of orthopedic device of 100b in FIG. 1B) by a change in ambient or implantation site temperature,by a release from deformation stresses, or by the introduction of anactivating medium or material. In certain embodiments, the orthopedicdevice is reversibly configurable between various shapes or geometries.

As mentioned previously, the orthopedic device may also comprise aclosed shape that forms a complete perimeter along at least one sectionor portion of the device. In FIG. 1D, for example, the orthopedic device130 a comprises an expanded configuration with a closed triangularshape. Although the triangular shape in FIG. 1D comprises an equilateraltriangular shape with uniform angles 135 a, 140 a and 145 a, in otherembodiments, one or more angles may be different from the other angles.Also, although the inner angles 135 a, 140 a and 145 a, along with outerangles 150 a, 155 a and 160 a have sharp angles, in other embodiments,one or more of these angles may be rounded. In its collapsed state,depicted in FIG. 1E, the inner angles 135 b, 140 b and 145 b of theorthopedic device 130 b may narrow to collapse its triangular shape intoan arrow shape. The orthopedic device 130 b may also have a bendingsection 165 a that collapses from a straight configuration to a bentconfiguration to facilitate the reduction in the cross-sectional profileof the orthopedic device 165 b. Although the orthopedic device 130 b isdepicted as generally collapsing within the plane of the orthopedicdevice 130 a in its expanded configuration, in some embodiments, thisand other orthopedic devices disclosed herein may also fold ontothemselves or otherwise collapse out of plane to reduce theircross-sectional profile. In other embodiments, the orthopedic device maycomprise other polygonal shapes or curvilinear shapes, with anglesand/or sides that may be uniform or different, with angles that narrowor widen when changing from one configuration to another configuration.Although several embodiments described herein have a base configurationthat is the expanded or deployed configuration, in other embodiments,the base configuration may be the delivery configuration. In still otherembodiments, the orthopedic device may comprise a malleable or plasticmaterial or structure with any bias toward one or more configurations.

FIGS. 1F and 1G illustrate another embodiment of an orthopedic device170 a/170 b comprising a closed arcuate configuration. In its deployedconfiguration, the orthopedic device 170 a comprises a circularconfiguration, but other embodiments, may comprise an oval or ovoidshape (e.g. one end being larger than the other end). To transform thedevice 170 a to its delivery configuration, the orthopedic device 170 ashortens along a first dimension 175 a while lengthening along a seconddimension 180 a. In some embodiments, the delivery axis of theorthopedic device 170 b may be transverse to the first dimension 175 b,or parallel to the second dimension 180 b.

One example of a nautilus-style spiral arcuate configuration is theembodiment of an orthopedic device 100 c as shown in FIG. 1C. Theorthopedic device 100 c has a proximal end 110 c and a distal end 120 cin relation to insertion into the body of a patient, such as into ajoint. In certain embodiments, orthopedic device 100 c has many similarattributes and characteristics of orthopedic device 100 a and/or 100 b,such as shape memory and/or an articular surface 105. In certainembodiments, orthopedic device 100 b is an arcuate configuration oforthopedic device 100 a. In certain embodiments, the orthopedic deviceof 100 a may be altered in to a configuration as shown for orthopedicdevice of 100 c. The bias may be a preferred configuration for aflexible, pliable, bendable device. In certain embodiments theorthopedic device 100 a, when unconstrained, can change to theconfiguration as shown for orthopedic device of 100 c, or by a change inambient or implantation site temperature or the introduction of anactivating medium or material. In certain embodiments, the orthopedicdevice is reversibly configurable between various shapes or geometries.

In some embodiments, the orthopedic device is configured to float insidethe joint, which may better conform to the natural movement of the bonesthrough the range of motion of the joint. The nautilus-style spiralarcuate configuration depicted in FIG. 1C, for example, may also offercertain advantages described for the open hoop arcuate configuration, orhoop configuration, but also provides a larger bearing surface to thejoint. With the extended length of the spiral configuration, theorthopedic device 100 c is configured to provide more of an articulatesurface, which may result in decreased pressure on the bones bydissipating forces over a larger surface area. The cross-sectionaldiameter multiplied by the number of winds in a spiral shape roughlyequals the surface area coverage of the articular surface inconformation with the bones of the joint. For example, a smallcross-sectional diameter of a spiral configuration allows for aplurality of windings in the spiral. This plurality of spiral windingscan then adjust to the general surface area of either bone as the jointarticulates.

As noted previously, some embodiments of the devices can have additionalstructures within it. For example, in FIG. 2 an orthopedic device 200comprises an elongate core 240 and an articular layer 230 surrounding atleast a portion of the core 240. Referring back to FIGS. 1A-1C, variousembodiments of orthopedic devices 100 a, 100 b and/or 100 c can eitherhave an elongate core or lack an elongate core. Other embodiments oforthopedic devices 100 a, 100 b and/or 100 c may also either have anarticular layer or lack an articular layer. Thus, the orthopedic devicemay consist of an elongate core, an articular layer, or both. In variousembodiments directed to use in PIP, DIP and MCP joints, for example, thecross-sectional diameter or thickness of a core can range from roughlyabout 0.001 to about 0.60 inches (or about 0.025 to about 15 mm) withsome embodiments in a range of roughly about 0.005 to about 0.015 inches(or about 0.13 to about 0.38 mm), and some embodiments in a range ofroughly about 0.01 to about 0.0125 inches (or about 0.26 to about 0.32mm). In various embodiments, the cross-sectional outer diameter oroverall thickness of an articular layer can range from roughly about0.003 to about 0.50 inches (or about 0.076 to about 12.7 mm) with someembodiments in a range of roughly about 0.039 to about 0.118 inches (orabout 1 to about 3 mm), and some embodiments in a range of roughly about0.078 to about 0.098 inches (or about 2 to about 2.5 mm). In someembodiments a ratio of core cross-sectional diameter (or thickness) toarticular layer cross-sectional outer diameter (or thickness) can rangefrom about 0.000 to about 0.500 inches, and in other embodiments mayhave ranges of ratios from about 2 to about 30. Other dimensions withthe same, similar or different ratios can be used in other parts of thepatient's body. Orthopedic devices with cores having other dimensionsmay also be used, including but not limited to orthopedic devicesconfigured for larger joints such as the knee, hip, ankle, and shoulder,for example.

As illustrated in the embodiment of FIG. 2, the orthopedic device 200may include the elongate core 240 in addition to the articular layer230. In some embodiments, the articular layer 230 surrounds,encapsulates, encloses or covers at least a portion of the core 240. Insome other embodiments, the articular layer 230 can surround orencapsulate the entire elongate core 240. As used herein, “surround,”“encapsulate” and “enclose” include configurations in which a core isnot completely surrounded, completely encapsulated or completelyenclosed. For example, certain embodiments of an orthopedic devicecontemplate an articular layer which “surrounds” an elongate core with acontinuous or non-continuous helical band, discontinuous tabs, or otherintermittent articular layer structure.

In some embodiments, the articular layer 230 may have some or all of thefeatures of other articular layer embodiments described herein. In oneembodiment, the ratio of the cross-sectional size of the elongate core240 to the articular layer 230 is in the range of about 10:1 to 1:10,sometimes in the range of about 5:1 to about 1:5 and other times with aratio of about 2:1.

In one embodiment, the elongate core 240 comprises a shape memorymaterial. The shape memory material may be made from a heat set/shapedshape-memory material, such as Nitinol, or a shape memory plastic,polymeric, synthetic material. For example, one embodiment of theelongate core 240 comprises a shape memory material including a shapememory polyurethane or polyurethane-urea polymer, as described above. Inone embodiment the elongate core 240 comprises a metal “open” ring suchas Nitinol encapsulated by an articular layer 230, or outer blanket,comprising silicone. In one embodiment the elongate core 240 comprises ahardened polymer. In one embodiment, the elongate core 240 is configuredsuch that a heat set Nitinol with an arcuate configuration, such as anopen ring configuration, a horseshoe configuration, or a spiralconfiguration, can be straightened for delivery through cooling orplastic deformation, then recovered to its original heat-set shape oncereleased from a delivery system, such as one embodiment using a properlysized hypodermic needle. In one embodiment the elongate core 240comprises a non-shape memory material which can be bent or deformed.

In certain embodiments, the elongate core 240 is coated or impregnatedwith a drug or other therapeutic agents as described previously withrespect to the articular layer. The therapeutic agents of the elongatecore 240 may be the same or different from the therapeutic agents of thearticular layer or other layers or coatings of the orthopedic devices.

FIGS. 3A to 3E are longitudinal cross-sectional views of the orthopedicdevices 100 a to 100 c in FIGS. 1A to 1C with various configurations ofoptional support structures or cores. FIG. 3A is a schematiccross-sectional view of an orthopedic device 300 a comprising asubstantially straightened configuration. In this embodiment, the devicecomprises an elongate core 340 a and an articular layer 330 asurrounding at least a portion of the core 340 a. The articular layer330 a has a proximal end 331 a and a distal end 332 a. The elongate core340 a has a proximal end 341 a and a distal end 342 a. In oneembodiment, the orthopedic device 300 a may be a cross-sectional view ofthe orthopedic device 100 a described above, with a core 340 a. FIG. 3Bshows a device an elongate core 340 b and an articular layer 330 bsurrounding at least a portion of the core 340 b in an open hoop arcuateconfiguration. The articular layer 330 b has a proximal end 331 b and adistal end 332 b, while the elongate core 340 b has a proximal end 341 band a distal end 342 b. In one embodiment, the orthopedic device 300 bmay be a cross-sectional view of the orthopedic device 100 b describedabove. Certain embodiments of a spiral shaped device, such as is shownin FIG. 3C can have a single elongate core. For example, orthopedicdevice 300 c comprises a nautilus-style spiral arcuate configuration,the device comprising an elongate core 340 c and an articular layer 330c surrounding at least a portion of the core 340 c, the articular layer330 c comprises a proximal end 331 c and a distal end 332 c, and theelongate core 340 c has a proximal end 341 c and a distal end 342 c. Inone embodiment, the orthopedic device 300 c may be a cross-sectionalview of the orthopedic device 100 c described above.

In some embodiments, the elongate core may be wrapped around itself orcomprise of a number of distinct or separate sections or segments, asshown in FIGS. 3D and 3E. FIG. 3D shows an orthopedic device 300 d withan open hoop arcuate configuration. In one embodiment, the orthopedicdevices 300 d may be a cross-sectional view of the orthopedic device 100b described above, with an optional folded or overlapping core 340 d.The device 300 d comprises one or more elongate cores 340 d wrapped,braided or folded back along a length of the device, and an articularlayer 330 d surrounding at least a portion of the core(s) 340 d. Thearticular layer 330 d has a proximal end 331 d and a distal end 332 d.The elongate core 340 d in FIG. 3D comprises a unitary body with aproximal end 341 d, a distal end 342 d, an inner segment 350 d, a middlesegment 352 d and an outer segment 254 d. The segments 350 d to 354 dmay be interconnected as depicted in FIG. 3D, but in other embodimentsmay one or more segments may be separated. The segments of theembodiments described herein may themselves have subsegments, e.g. theinner segment 350 d may comprise a proximal segment and a distalsegment. Also, the segments of a core may generally have a similarlength, such as segments 350 d to 354 d in FIG. 3D, but one or moresegments may also have a different length In some embodiments forexample, two or more elongate cores 340 d are situated in a roughlyparallel or co-linear orientation, which can be twisted or braided orinterlocked. Other embodiments of the orthopedic device need not belimited to a single elongate core or backbone, but may have a pluralityof cores or backbones including a braided configuration, continuousoverlaps, etc. FIG. 3E shows an orthopedic device 300 e with anautilus-style spiral arcuate configuration. In some embodiments, theorthopedic device 300 e may be a cross-sectional view of the orthopedicdevice 100 c described previously, but with an optional folded oroverlapping core 340 e. The device 300 e comprises one or more elongatecores 340 e wrapped or folded along a length of the device and anarticular layer 330 e surrounding at least a portion of the core(s) 340e. Although the core 340 e generally extends from one end 331 e of theorthopedic device 300 e to the other end 332 e, in other embodiments,the core 340 e may extend out from the articular layer 330 e at eitheror both ends 331 e, 332 e of the orthopedic device 300 e, or anywherebetween the two ends 331 e and 332 e. In other embodiments, the core 330e may have a length that is substantially less than the length or theorthopedic device 300 e. For example, the core may be provided onlyalong the outer spiral portion of the orthopedic device, leaving theinner overlapping portion of the orthopedic device with a portion of thecore. In other embodiments, only the inner portion of the orthopedicdevice may comprise a core, while the outer overlapping portion lacks acore.

FIGS. 3F and 3G depict one embodiment of the orthopedic device 170 a and170 b depicted in FIGS. 1F and 1G configured with one or more optionalcores. As shown in FIG. 3F, in the orthopedic device 170 c in theexpanded configuration comprises two separate cores 180 c and 182 c. Inother embodiments, the orthopedic device may have a single core, orthree or more cores, including but not limited to four cores, fivecores, or six cores, for example. The cores may have substantiallysimilar lengths or their lengths may be substantially different. Thecores may also have substantially similar or different cross-sectionalor elongate shapes. In some embodiments, the cores 180 c and 182 c maybe separate but arranged in contact with each, or they may be separatedby non-core sections 184 c and 186 c at one or both ends 188 c, 190 c,192 c and 194 c of the cores 180 c and 182 c. In some embodiments, thenon-core portions of an orthopedic device may facilitate a particularcollapsed configuration. For example, the narrow oval configuration ofthe orthopedic device 170 d in FIG. 3G illustrates how the non-coresections 184 d and 186 d may permit substantial bending in the collapsedstate compared to portions of the orthopedic device 170 d along thecores 180 d and 182 d. In some embodiments, the perimeter or length ofthe orthopedic device, whether having an open or closed configuration,may comprise a ratio of core to non-core portions in the range of about0 to about 1, sometimes about 0.3 to about 1, and other times in therange of about 0.7 to about 0.95.

The shape of the elongate core can vary, as is shown in embodiments inFIGS. 4A to 4C. FIG. 4A shows an elongate core 440 a with one or moresubstantially linear or straight members. FIG. 4B shows an elongate core440 b with one or more wave, curve or zig-zag members that may be in oneor more planes at any angle with respect to one another. FIG. 4C showsan elongate core 440 c with one or more members in a braided or weaveconfiguration. Any of these patterns can be used with any of theelongate cores disclosed herein.

Various embodiments of elongate cores can have different features alongthe length or ends of the core, as is shown in FIGS. 5A-5C. An elongatecore 540 a with an open hoop arcuate configuration can have one or moreend segments, as is shown in FIG. 5A. Such end segments can includeproximal end segment 561 a and/or distal end segment 562 a. In someembodiments, the optional end segments 561 a and/or 562 a may beconfigured with an enlarged axial cross-sectional area compared to theportions of the core 540 a between the end segments 561 a, 562 a. Theend segments may have any of a variety of configurations, including butnot limited to the ring or loop configurations depicted in FIG. 5A. Inother embodiments, the end segments may have a T-tag configuration, aspherical or ovoid configuration, a helical or spiral configuration, orany other configuration. The orientation of the end segments may liewithin the plane of the rest of the orthopedic device, or may beperpendicular, transverse or some non-planar orientation with respect tothe orthopedic device. The configuration of each end segment, if any,may be the same or different. Each end segment may be embedded withinthe articular layer of the orthopedic device, but in some embodiments,some or all of the end segments may at least partially project from thearticular layer or otherwise be exposed with respect to the articularlayer. In one particular example, the end segments 561 a and 562 a ofFIG. 5A may be exposed so that the ring configurations may be used toattach a suture or other structure to the orthopedic device. In otherembodiments, the end segments 561 a and 562 a may help to resistrelative separation or displacement of the articular layer and the core540 a, and/or to reduce the risk that ends of the core 540 a maypenetrate through the articular layer of the orthopedic device. Invarious embodiments, the elongate core or cores 540 a can have zero,one, two or more end segments. In one embodiment the end segment 561 aor 562 a is radiopaque or can be used as a marker for visualization ofthe ends of the orthopedic device. The end segments 561 a and 562 a maycomprise the same or different material as the length of the elongatecore 540 a. In one embodiment, the end segments 561 a and 562 a areseparate elements made of the same or different material as the lengthof the elongate core 540 a and which are bonded, fused, welded, glued,or otherwise attached to the proximal end 541 a and a distal end 542 a,respectively.

Although not illustrated, it is contemplated that an elongate core 540 amay have one or more medial segments anywhere along the length of theelongate core 540 a. In various embodiments, elongate core 540 a has endsegments or medial segments to help improve stability of an articularlayer or outer blanket, and need not be flat or planar, but can bebiased out of the primary plane of the device at one end or both ends.

In another embodiment, an elongate core 540 b may include one or morebends, such as proximal bend 541 b and/or distal bend 542 b as shown inFIG. 5B. In some embodiments, the bends may also include hooks. Invarious embodiments, the bends or hooks can be closed off to form aloop, as with certain embodiments of elongate core 540 a. The bends 541b and/or 542 b may be generally oriented radially inward, as shown inFIG. 5B, or radially outward. The bends may or may not have the sameorientation. For example, the elongate core 540 c shown in FIG. 5Ccomprises a proximal segment 541 c that is bent radially inward from thecurvature of the elongate core 540 c and a distal segment 542 c that isbent radially outward with respect to the overall configuration of theelongate core 540 c. In other embodiments, proximal segment 541 c and/ordistal segment 542 c are bent radially inward, radially outward, and/orup or down from the primary plane of the elongate core 540 c. FIG. 5E,for example, depicts an embodiment of an orthopedic device 570 e withits ends 572 e and 574 e oriented out-of-plane in a relative upwarddirection. The orthopedic device 570 e may optionally comprise anarcuate core (not shown) with ends that are bent out-of-plane. Thus, inembodiments where the core of the orthopedic device comprises ends whichare biased or bent slightly towards or away from its center, theoptional core or support structure of the orthopedic device may besimilarly configured. In other embodiments, however, the generalconfiguration of the core and the general configuration of the articularlayer or the orthopedic device may be the same or may be different.

FIG. 5D schematically illustrates another embodiment of a non-planarorthopedic device. In this particular embodiment, the portions of theorthopedic device 570 d at each end 572 d and 574 d may have a generallyplanar configuration, with by a compressible axial member 576 dtherebetween. The axial member 576 d may have a multi-angleconfiguration, as shown in FIG. 5D, but may also comprise a multi-curvedor helical configuration, for example. In some embodiments, the planarends 572 d and 574 d of the orthopedic device may facilitate thealignment of the orthopedic device 570 d with the articulating surfacesof bones of a joint. In some embodiments, the orthopedic device with amulti-planar configuration may augment the shock absorbingcharacteristics of the orthopedic device, including orthopedic devicesthat undergo frequent or substantial axial loading, such as a kneejoint. Here, the configuration of the axial member 576 d may modify theaxial loading characteristics of the joint relative to an orthopedicdevice with a generally planar configuration.

In embodiments of the orthopedic devices comprising elongate cores, thecores may have any of a variety of cross-sectional structures orprofiles. For example, some cross-sectional profiles of variousembodiments of elongate cores are shown in FIGS. 6A to 6K. Theillustrated embodiments are not limiting, but merely examples of variouspossible cross-sectional profiles of any of the embodiments of elongatecores or orthopedic devices described herein. The illustratedembodiments shows a variety of possible cross-sectional shapes forembodiments of the device or the core of the device, including a square,ellipse, triangle, etc., and wherein the elongate core can be modifiedby twisting, and zig-zagging, and/or undergo one or more surfacetreatments such as abrading or pitting, for example.

FIG. 6A illustrates a cross-sectional view of an embodiment of acircular profile elongate core 640 a, which can be rotated along alongitudinal axis of the core 640 a. In various embodiments, theelongate core 640 a is at least partially surrounded by an articularlayer, wherein the elongate core 640 a and/or the articular layertransition between a straight or slightly curved configuration to a morecurved or arcuate configuration. During this change in configuration,elongate core 640 a and the articular layer may rotate with respect toeach other. In one embodiment, the elongate core 640 a and the articularlayer has some frictional engagement, which may interfere with rotationbetween the elements, resulting in some level of deformation.Furthermore, in one embodiment, both the elongate core 640 a and thearticular layer will have different material properties which aredependent on stiffness, durometer and other aspects of the respectivematerials. Depending on the desired orientation of an orthopedic deviceduring delivery to a joint, the orientation of the elongate core 640 aand/or the articular layer may be controlled by the configuration of thedelivery device being used.

In certain embodiments, an elongate core may be configured with anon-circular cross-sectional shape. For example, FIGS. 6B to 6Killustrate cross-sectional views of a triangular profile elongate core640 b, a rectangular profile elongate core 640 c, a trapezoidal profileelongate core 640 d, an oval or elliptical profile elongate core 640 e,a ridged profile elongate core 640 f, a non-symmetric profile elongatecore 640 g, a cross or X-profile elongate core 640 h, a lumen profileelongate core 640 i, a pentagon profile elongate core 640 j, and ahexagon profile elongate core 640 k, respectively. In some embodiments,a non-circular profile may be used to resist or limit relative rotationor torsion of an articular layer and the core. Although several of theembodiments disclosed herein comprise one or more cores with an elongateconfiguration, in other embodiments, the cores may comprise a branchingor interlinking structure that may have a generally planar or agenerally non-planar structure. For example, some orthopedic devices mayhave a core with a “Y”-shape or “X”-shape branched configuration, withthe arms or segments of the core arranged in a generally the same plane.Other orthopedic devices may also have a “Y”-shape or “X”-shape branchedconfiguration but in a non-planar arranged, such as a three-leg orfour-leg tripod arrangement, for example, where the intersection pointof the “Y”-shape or “X”-shape is located in a different plane as one ormore of the ends of the arms or segments. Embodiments of orthopedicdevices having branched cores may or may not have articular layers arealso branched, and embodiments of orthopedic devices with branchedarticular layers may or may not have branched cores.

In some embodiments, the articular layer of the orthopedic device mayalso comprise a non-circular cross-sectional shape. The cross-sectionalshape of elongate core of such orthopedic devices, if any, need not havethe same or similar the cross-sectional shape of the articular layer. InFIGS. 6L and 6M, for example, the orthopedic device 642L comprises anarticular layer 644L with a rectangular axial cross-sectional shape andan elongate core 640L with a circular axial cross-sectional shape. Thelarger dimension 646L, if any, of the rectangular articular layer 644Lmay be generally oriented within the plane 648L of the orthopedic device642L, while the shorter dimension 650L, if any, (or a dimensiontransverse to the larger dimension 646L) may be generally orientedtransverse to the plane 648L of the orthopedic device 642L. In otherembodiments, the orientation may be opposite, or may be at any otherangle or orientation with respect to the plane of the orthopedic device,if any, or other geometric reference of the device, including but notlimited to the longitudinal axis or a center axis of the orthopedicdevice, if any. The core 640L of the orthopedic device 640L may begenerally centered along the larger dimension 646L and the shorterdimension 648L, e.g. at a position about 50% along the larger dimension646L and the shorter dimension 648L. In other embodiments, the relativeposition of the core 640L may be located anywhere from about 0% to about100% along a particular dimension, including about 10%, about 20%, about30%, about 40%, about 60%, about 70%, about 80% and about 90%, forexample. The relative position of the core may be generally uniformthroughout the orthopedic device, or may vary depending upon theparticular section of the orthopedic device. In further embodiments,where a portion of the core extends beyond an inner or bottom surface,or an outer or upper surface of the articular layer with respect to aparticular dimension, the relative position may be expressed as anegative percentage or a percentage greater than 100%. In someembodiments, for example, the position of the core may be located atabout −10%, about −20%, about −30%, about −40% or about −50% or lower,or about 110%, about 120%, about 130%, about 140% or about 150% orgreater. The orthopedic device in FIG. 6L also illustrates that theC-shape or arcuate configurations described herein are not limited togenerally circular devices, and may include generally oval devices.

FIGS. 6N and 6O depict another embodiment of an orthopedic device 642N,comprising an articular layer 644N with a cross-shape cross-sectionalshape along with a circular core 640N. FIG. 6P depicts anotherembodiment of an orthopedic device 642P, comprising a triangulararticular layer 644P and a circular core 640P. In contrast to orthopedicdevices 642L and 642N in FIGS. 6L and 6N, respectively, which depictopen configurations, FIG. 6P illustrates an orthopedic device 642P witha closed configuration, as well as a cross-sectional shape that variesfrom one section 652P to another section 654P. Both features, however,need not be found in the same orthopedic device. In this particularexample, one section 652P comprises an isosceles triangular shape whilethe other section 654P comprises an equilateral triangular shape. Thedifferent shapes of two or more sections of an orthopedic device, ifany, may share one or more shape features (e.g., both may be triangularor polygonal), but in other embodiments, may be completely different(e.g. one section may have a small circular shape, while another sectionmay have a large irregular octagonal shape).

FIG. 6R depicts still another embodiment of an orthopedic device 642R,comprising an articular layer 644R that has a non-polygonalcross-sectional shape that is non-uniform, along with a non-circularcore 640R. As shown in FIG. 6S, one section 652R of the articular layer644R comprises a superior protruding edge 656R and an inferiorprotruding edge 658R, both of which have a reduced profile in othersection 654R of the device 642R. Furthermore, the inner protrusion 660Rof one section 652R may also have a different profile compared toanother section 654R. Still another feature of the device 642R is thepresence of a second core 662R within the articular layer 644R. In thisparticular embodiment, unlike the primary core 640R, the second core662R may be located in only a portion of the device 642R, such as theinferior protruding edge 656R, and may not extend along the entirecircumference or perimeter of the device 644R.

FIGS. 6T and 6U depict another embodiment of an orthopedic device 642T,comprising a core 640T, an articular layer 644T and a span member 674Tthat crosses at least a portion of the inner region 676T of theorthopedic device 642T. In this particular embodiment, the span member674T comprises a membrane having a generally uniform thickness and aplanar configuration located generally midway between the superiorsurface 678T and the inferior surface 680T of the orthopedic device640T. In other embodiments, the span member have a variable thickness,including one or more openings, depressions or grooves along one or moresurfaces of the span member. In addition to planar configurations, thespan member may have one or more regions with a non-planarconfiguration, including corrugated, concave, or convex regions, forexample. The span member 674T may comprise the same or differentmaterial as the articular layer 644T, and may or may not be attached orembedded with reinforcement structures, e.g. wires, struts or meshes.

FIGS. 6V and 6W depict one example of an orthopedic device 642V with aspan member 674V comprising a membrane structure with a convexconfiguration with respect to the superior surface 678V of theorthopedic device 642V. The span member 674V further comprises one ormore through openings 682V arranged in a grid-like order, and with agenerally cylindrical shape on cross-section, as shown in FIG. 6W. Inother embodiments, one or more openings may have a non-circular shape(e.g. elliptical, ovoid, squared, rectangular, trapezoidal, orpolygonal), have a non-uniform shape or diameter (e.g. tapered,toroidal), have a non-linear elongate configuration (e.g. angled orundulating), or any combination thereof.

FIG. 6X depicts another embodiment wherein a plurality of span members674X are provided across the inner region 676X of the orthopedic device642X. As shown in FIG. 6X, the span members 674X has an elongateconfiguration with a generally parallel orientation with respect to oneanother. In other embodiments, however, one or more span members mayhave a non-parallel or overlapping configuration with respect to anotherspan member. Each of the span members 674X may be symmetrically orientedwith respect to a midline through the orthopedic device, but may also beasymmetrically oriented. The span members 674X in FIG. 6X have any of avariety of cross-sectional shapes (e.g. circular, elliptical, ovoid,squared, rectangular, trapezoidal, or polygonal), and may have uniformor non-uniform cross-sectional areas or shapes along their elongatelength.

As mentioned previously, the articular layer of the orthopedic devicemay comprise a smooth outer surface, or a porous or textured surface. InFIG. 6Y, for example, the articular layer 644Y of the orthopedic device642Y comprises a textured surface with series of ridges having arepeating angular or oscillating pattern. As mentioned previously, inother embodiments, the textured surface may comprise other types ofsurface structures, including but not limited to discrete or aggregatedmicrostructures or nanostructures, such as grooves, pores, indentations,hooks, barbs, tubes, rods, cones, spheres, cylinders, loops, pyramids,or a combination thereof. The surface of the orthopedic device or itsarticular layer may be completely or partially covered with the surfacetextures, and the density, spacing or size of the ridges or othersurface structures may be uniform or non-uniform. In the embodimentdepicted in FIG. 6Y, the ridges generally have the same orientationregardless of the particular section of the articular layer 644Y, but inother embodiments, the ridges, structures or textures may be aligned ororiented in any of a variety of other ways, including but not limited towith respect to the longitudinal axis of the orthopedic device 644P, orcircumferentially around the device 644Y, for example.

In some embodiments, larger structures may be provided on the surface ofthe orthopedic device, in addition or in lieu of surface texturing. InFIG. 6Z, for example, an orthopedic device 644Z comprises a C-shapeconfiguration with one or more ridges or flanges 664Z having a size thatalters a gross dimension of the orthopedic device 644Z by about 5% ormore. In this specific example, the flanges 664Z have a circumferentialconfiguration around the body of the orthopedic device 644Z and areangled such that the narrow end 666Z of the flange 664Z is closer to themiddle portion 668Z of the orthopedic device 644Z while the wider end670Z of a flange 664Z is closer to the ends 672Z of the orthopedicdevice 644Z. In other embodiments, the larger structures may compriselarge grooves or indentations, or other types of projecting surfacestructures. These larger structures may be rigid, semi-rigid orflexible, and each structure can have the same or a differentconfiguration, size or material composition. In some embodiments, theflanges 664Z may resist migration or displacement of the orthopedicdevice 644Z within the joint space and/or out of the joint capsule.

In one embodiment, the articular layer can be at least partiallyattached to the outer surface of a portion of a backbone or core, eitherduring or after implantation. In one non-limiting example, a core orbackbone or wire of fixed length is implanted in a joint, then anarticular layer or jacket is advanced over the core. In alternativeembodiments, the articular layer is positioned in the joint first,followed by the insertion of the core through the articular layer. Thecore or backbone or wire is cut to size for a joint and is implanted ina joint, then an articular layer or jacket is advanced over the core.The articular layer or jacket may also be shaped or sized before beingadvanced over the core. In various embodiments, the core could have afeature such as a ball or hook at one or both ends (proximal and distal)so that when the articular layer is advanced over the proximal end ofthe core, the articular layer can abut against a distal feature or stop.In still other embodiments, the core may comprise a roughened outersurface, barbs, or other interference structures that resist separationfrom the articular layer. In an embodiment with a proximal feature suchas a ball or cap, the articular layer may be trapped or held in positionbetween the features to resist separation from the core. In otherembodiments, heat bonding or adhesives may be used to attach thearticular layer to the core. In one embodiment the articular layer canbe implanted without a backbone or core.

Some embodiments of an elongate core include a plurality ofinter-connectable discrete elongate members, as shown in FIGS. 7 to 9C.In various embodiments, two or more discrete articular structures ormembers may be connected along a single core wire or a plurality of corewires or elements. In embodiments comprising a plurality of coreelements, a separate core element may be used to connect each adjacentpair of articular members, or multiple core elements may be used. Inother embodiments, one or more discrete articular members are configuredto facilitate or permit rotation or spinning about the connector or corewire. In another embodiment one or more discrete elongate members areaffixed to the connectors or core wire in a manner to reduce or preventrotation of the elongate members with respect to connector or core wire.For example, multiple core wires may be beneficial in resisting rotationof an articular structure around a single core element. As illustratedin FIG. 7A, one embodiment of an orthopedic device 740 a comprising aplurality of inter-connectable discrete elongate members 742, 744 and746 which are linked by connector 760. In some embodiments, theconnector 760 can be a single core member extending between all thediscrete elongate members 742, 744 and 746, or it can be any number ofdiscrete connecting members between the elongate members. In oneembodiment, the connector is flexible or malleable such that orthopedicdevice can be arranged in a variety of non-linear configurations. InFIG. 7B, for example the orthopedic device may be manipulated toorthopedic device 740 b with a plurality of independent orinter-connectable discrete elongate members 742, 744, 746 and 748 canhaving a “W”-shape generally rectilinear configuration. The connectors760 can be configured to orient the elongate members such as 742, 744,746 and 748 in any number of orientations or angles, in or out of plane.In some embodiments, the connectors 760 can have shape memoryconfigurations or biases for particular orientations, depending on thedoctor's preference or the device selected. The overall shape of anorthopedic device may comprise a “C”, “O” and “W”-shape, but the deviceand/or articular layer and/or elongate core can specific any shape orconfiguration or general class of shape or configuration as mentionedelsewhere herein. FIG. 8 illustrates an alternate embodiment where theorthopedic device 840 comprises non-elongate interconnected articularmembers 841, 842, and 843 which are linked by a connector 860 passingthrough each member 841, 842 and 843, for example. The articularmembers, may have any of a variety of other shapes and configurations,and need not have a uniform size and shape, or comprise the samematerial.

In some embodiments, the orthopedic device may be marked to indicateorientation of the device. For example, the orthopedic device can bemarked with any of a variety of graphical or other detectable indicia,including but not limited to a symbol, text, colors, magneticradiographic markers or inks, or other types of markings that can besensed visually or otherwise with or without the assistance of sensorsor other devices, to indicate a side or feature that should be directedto a specific location. In some embodiments, identifying the orientationof an orthopedic device when it is deformed to a substantiallystraightened configuration may be addressed by markings or other indiciaon the device to provide an indication of the orientation of the device.The indicia can be helpful for checking proper function or delivery ofthe orthopedic device. In some embodiments, the device or a componentthereof may comprise a material that has electroresistive property whichmay change when the device or component is stressed or deformed. Changesin these or other electrical properties may be used as assess the forcesacting on the device.

In some embodiments, the orthopedic device may comprise one or morearticulations to facilitate configuration changes, in addition or inlieu of flexible interconnecting structures and/or materials. In oneembodiment, for example, an elongate core 940 a may comprise a pluralityof inter-connectable discrete members, or links 950 a, in asubstantially straightened configuration, as shown in FIG. 9A. Theelongate core 940 a may be described as a multi-link elongate core,multi-link core, multi-link orthopedic device, or multi-link orthopedicimplant. The multi-link orthopedic device may comprise a series of rigidor flexible links configured to translate the multi-link core from astraight or slightly curved configuration into a curved orientation orconfiguration. The diameter of curvature of the device could beadjustable by the ratcheting features provided on each link 950 a. Inone embodiment the links 950 a are made of a material that can undergosome level of elastic deformation. In another embodiment, the links 950a are made of a more rigid material. With embodiments of the device,core, or link that are made from a superelastic material such asNitinol, the implant can be straightened from its curved, deployed orimplanted configuration and placed in a needle or cannula. Using anangled or curved delivery system, such as one shown in FIG. 10C below,would allow a more-rigid arcuate implant to be slightly straightenedenough for insertion, but not enough to cause yielding.

FIG. 9B shows a side view of one link 950 b. In one embodiment, link 950b is a link 950 a of FIG. 9A. In one embodiment link 950 b comprises afirst end 951 and a second end 952. Various links 950 b areinter-connectable between the second end 952 of a first link 950 b andthe first end 951 of a second link 950 b′, and in one embodiment theinterconnection is a hinged connection between a first link interface990 and a second link interface 980. In other embodiments, otherconnections or joints may be used, such as a ball-and-socket joint, apivot joint, or a saddle joint, for example. Each link connection neednot be the same type of connection. In one embodiment, the first linkinterface 990 is a post and the second link interface 980 is a channelin which the post is captured to allow rotation. In another embodiment,the second link interface 980 is a post and the first link interface 990is a channel in which the post is captured to allow rotation. In variousother embodiments, other link interfaces allowing some rotationincluding snap fits, connectors, or other similar interfaces may beused. In the illustrated embodiment, the link 950 b comprises a ratchetprong 960 and ratchet teeth 970. The ratchet teeth 970 of one link 950 binteract with the ratchet prong 960 of a second link 950 b′ to allowrotation with respect to links 950 b and 950 b′ while restricting orlimiting rotation in the opposite direction.

Various link embodiments may be configured to an arcuate configuration,as in FIG. 9C, which shows an elongate core 940 c with links in anarcuate open loop configuration. In one embodiment, the elongate core940 c is actuated and locked into an arcuate configuration by theratcheting mechanism as described above. In one embodiment the ratchetlocking is configured to be disengageable such that the prong isreleasable from the teeth to allow the elongate core 940 c to rotate ina straight or less-curved configuration.

The orthopedic devices described herein may be implanted using any of avariety of implantation procedures. Although certain embodiments areconfigured for minimally invasive implantation, surgical implantationusing an open procedure is also contemplated. The orthopedic devicedescribed herein may be implanted or be adapted for implantation into avariety of joints, including but not limited to the DIP and PIP jointsof the hands and feet, the metatarsal-phalangeal joints, thetarsal-metatarsal joints, the metacarpal-phalangeal joints, thecarpal-metacarpal joints, the ankle joints, the knee joints, the hipjoints, the joints of the spine, including the facet joints, theglenohumeral joint, the elbow joint, the temporomandibular joint andothers.

For example, in one embodiment, an arcuate orthopedic device is removedfrom its sterile packaging and optionally soaked in sterile saline. Thejoint is palpated or otherwise identified, with or without traction orother joint manipulation (e.g. flexion, extension). The skin regionabout the patient's affected joint is prepped and draped in the usualsterile fashion, and local, regional or general anesthesia is achieved.An anesthetic such as Marcaine, or other type of fluid such assterilized water or a contrast agent, may be injected into the joint tocause joint distraction. As depicted in FIGS. 10A and 10B, an arthrotomyincision 1100 is made through the joint capsule 1102 of the joint 1104to access the joint space 1106. In some embodiments, the arthrotomyincision may be performed using a stab or cut incision from a trocar ora scalpel 1108, for example. The joint space 1106 may be optionallyirrigated, and any osteophytes and/or loose cartilaginous material maybe removed.

In some embodiments, the incision 1100 or opening may be large enough toinsert the orthopedic device without requiring its deformation, but inother embodiments the incision 1100 may be smaller than the insertionprofile of the orthopedic device. A Freer elevator, or other type oftissue retracting tool, may optionally be placed into the incision 1100or opening to facilitate insertion of other components into the jointspace. Referring next to FIGS. 10C and 10D, a needle 1110 is theninserted through the incision 1100 or opening and passed through jointspace 1106 until it reaches a portion 1112 of the joint capsule 1102opposite the incision 1100 and penetrates through the opposite skinsurface. As the needle 1110 passes through the capsular and skin tissue,a suture 1114 or other tether structure coupled to the needle 1110 andto an orthopedic device 1116 is pulled through the joint space 1106along with the orthopedic device 1116. As illustrated in FIGS. 10E and10F, as the orthopedic device 1116 traverses the incision 1100 oropening, the orthopedic device 1116 may deform or collapse to better fitthrough a smaller incision 1100 or opening. In FIGS. 10G and 10H, as theorthopedic device 1116 passes through the incision 1100 or opening andinto the joint space 1106, the orthopedic device 1116 may revert orexpand back to its native configuration. In some embodiments, the suture1114 is pulled until no portion of the orthopedic device 1116 remains inthe incision 1100 or opening. In other embodiments, the sutures 1114 maybe pulled until the orthopedic device 1116 abuts against the portion1112 of the joint capsule 1102 opposite the incision 1100. The pathway1118 through which the needle and suture exit the joint 1104 typically,but not always, has a smaller cross-sectional area than the incision1100 or opening through which joint access is provided. In someembodiments, a trailing suture (not shown) may be coupled to theorthopedic device to permit withdrawal or repositioning of theorthopedic device through the initial incision. The trailing suture, ifany, may be coupled to the orthopedic device using the same or differentsuture lumen or coupling mechanism.

As depicted in FIGS. 10G to 10J, once the position of the orthopedicdevice 1116 is confirmed, the suture 1114 may be cut or manipulated topermit removal of at least a portion of the suture 114 from the patient.In the depicted embodiment, the suture 1114 may be cut using the scalpel1108 (or other instrument) to permit the loop 1120 of the suture 1114 tobe pulled away from the orthopedic device 1116. Once positioning,deployment and functioning of the orthopedic device 1116 is confirmed,the incision 1100 and/or the needle pathway 1118 may be closed. In someembodiments, closure may be performed using sutures, staples and/oradhesives. In some instances where the incision or the needle pathwaymay be self-sealing and no specific closure procedure is required. FIGS.10K and 10L depict the orthopedic device 1116 in its final implantedstate and the joint capsule closed. The incision may then be dressed, oran optional splint, cast, or other immobilizing or restraining devicemay be applied to the joint or body region. In some embodiments, thejoint space may be filled or infiltrated with one or more therapeuticagents before, during or after the device implantation. As mentionedpreviously, the therapeutic agents may include but are not limited to anantibiotic, an anti-inflammatory agent, or a viscosupplement (e.g. hylanG-F 20 such as Synvisc®, or various formulations of sodium hyaluronatesuch as Hyalgan®, Suppartz®, Euflexxa® and Orthovisc®).

In other embodiments, a portion of the suture may be left in the bodyalong with the orthopedic device. For example, the loop of suture may bepermanently affixed to the orthopedic device, such that the suture maybe cut close are at the skin surface, leaving a portion of the sutureattached to the implanted orthopedic device. In some embodiments,tensioning the suture results is transient displacement of theorthopedic device from its base location, and when the exposed portionof the tensioned suture is severed, the unexposed portion is pulled intothe body as the orthopedic device retreats back toward its baselocation.

Although the access procedure described generally above may be appliedto any of a variety of joints, in certain embodiments described herein,the orthopedic devices may be sized and configured for implantation inthe joints of the hands and wrists. As mentioned elsewhere herein, thesejoints include the DIP and PIP joints, the MCP joints and thecarpo-metacarpal (CMC) joints, as well as the variety of joints betweenthe proximal and distal carpal bones (e.g. scaphoid, lunate, triquetrum,trapezium, trapezoid, capitate, hamate, pisiform), as well as the jointsformed between the carpal bones and the radius and ulna. In someembodiments, accessing the joints of the hand and/or wrist may involvemaking an entry incision on the dorsal side of a joint, such as the CMCjoint at the base of a patient's thumb (CMC-1 joint), and using theneedle to deliver an orthopedic implant by having the needle exit theCMC-1 joint on the palmar side of the joint. In other embodiments, theentry incision may be made on the palmar side of the joint with theneedle exiting the dorsal side. One of skill in the art will understandthat one or more needles and other combinations of the entry and exit ofthe needle are also contemplated, including but not limited to accessprocedures where the entry and exit of the needle may occur throughseparate pathways on the same side of a joint (e.g. dorsal/dorsal, orpalmar/palmar) or through the medial or lateral side of a joint (e.g.palmar/lateral, palmar/medial, dorsal/lateral, dorsal/medial,lateral/medial, medial/lateral, etc.).

The needle or other penetrating member used to pull the orthopedicdevice into the joint space may have any of a variety of sizes andconfigurations. The particular size and configuration may vary and maybe based upon the particular joint, the particular access method (e.g.percutaneous vs. cut-down) and other related anatomy (e.g. intra-jointligaments, extra-capsular ligaments), and/or the type of needle driver(if any), and the size and configuration of the orthopedic device, forexample. Other penetrating members may include trocars or rigid wires(e.g. Kirschner wires). In some embodiments, a through lumen may beprovided along part or the entire penetrating member.

In some embodiments, other access procedures to the joint may beprovided. For example, rather than a stab incision or limited accessincision, the skin may be dissected until the joint capsule is exposed,and then a cut is made to form a flap to achieve a larger access openingto the joint. In other embodiments, the exit pathway for the needle andsuture may also be created or at least enlarged using a stab incisionfrom a scalpel, or by forming a flap. In another embodiment, a cannulaor delivery instrument is inserted through the joint capsule and intothe joint space. Various embodiments of delivery instruments that may beused are described in U.S. application Ser. No. 12/099,296, filed Apr.8, 2008. As depicted in U.S. application Ser. No. 12/099,296, someembodiments of the delivery instrument may comprise a penetrating memberthat may be used to access a joint without a guidewire or introducer. Asmall opening in the joint capsule may be formed by the penetration thecannula or delivery instrument, or by the use of a scalpel or trocar,for example.

In some embodiments, instead of using a needle and suture to pull theorthopedic implant into the joint, the orthopedic device (or other typeof resilient or shape-memory orthopedic device) may be grasped withfingers or with forceps and inserted into the joint. In someembodiments, the arcuate orthopedic device may be squeezed or restrainedto reduce its profile while being inserted into the joint. Onceinserted, the restraining force acting on the orthopedic device isrelieved to permit reversion to its larger profile. The surgeon canreposition the orthopedic device in the joint to achieve the desiredposition. The capsule and incision are then closed with a suture and ora dressing (e.g. bandage). In other embodiments, other suture sizes,suture techniques and/or resorbable suture material may be used.

Verification of the position of the various delivery components or theorthopedic device during one or more phases of the implantationprocedure may include ultrasound, x-ray imaging, fluoroscopy and MRI. Insome instances, verification of the integrity of the joint capsule maybe performed to assess the potential for the orthopedic device tomigrate or dislodge from the joint.

In another embodiment, the orthopedic device may be inserted in aminimally invasive manner under direct visualization using fluoroscopy,fiberscope or arthroscope. In other embodiments, a limited accessprocedure using a surgical microscope may also be performed. Theinsertion of the fiberscope or arthroscope into the joint may beperformed percutaneously or by a cut-down procedure as exemplifiedabove, or by other access methods. In some embodiments, the arthroscopemay comprise a multi-lumen arthroscope with one or more workingchannels. The working channels may be used to provide joint irrigationand/or to insert various instruments to smooth the joint surfaces or tocauterize any bleeding that may have occurred, for example.

FIG. 10 depicts one embodiment of a penetrating member 1000, comprisinga penetrating section 1002, a suture coupling section 1004 and a body1006 there between. The length of the penetrating member 1000 may be inthe range from about 1 to about 14 cm, sometimes about 2 to about 5 cm,and other times about 2 to about 4 cm. The diameter or transversedimension of the penetrating member 1000 may be in the range of about0.5 to about 5 mm or more, sometimes about 1 to about 3 mm, and othertimes about 1.5 to about 2.5 mm. The penetrating member 1000 in FIG. 10has a linear-shape penetrating section 1002 and body 1006, but in otherembodiments, one or more of the tip, body, or suture coupling sectionmay be may curved or non-linear. In some embodiments, the penetratingmember 1000 may comprise a ¼ curve, a ⅜ curve, a ½ curve, a ⅝ curve or acompound curve, for example.

The penetrating section 1002 of the penetrating member 1000 may comprisea sharpened tip 1008 or one or more sharpened edges. The penetratingsection 1002 may comprise a tapered tip, a spatula or spade tip, or atriangular cutting tip, for example. In other embodiments, thepenetrating member 1000 may have a blunt tip. The sharpened tip 1010,1012 may be located centrally with respect to the body 1014, as shown inFIG. 12A, or eccentrically with respect to the body 1016, as shown inFIG. 12B. The taper distance 1018, 1020 and/or taper angle 1022, 1024may vary, and may depend upon the particular penetration characteristicsof the joint and/or access procedures, for example.

As illustrated in FIGS. 13A to 13C, any of variety of structures ormethods may be used to couple a suture to the penetrating member. InFIG. 13A, for example, the suture coupling section 1026 comprises aneyelet 1028 or other aperture structure through which a suture 1030 maybe threaded. Although the suture 1030 in FIG. 13A is depicted as beingslidably coupled to the eyelet 1026, in other embodiments, one or moresuture knots may be used to further secure the suture to the penetratingmember. The suture knots used may include but are not limited to squareknots, half hitch knots, bowline knots, granny knots or surgical knots.Heat bonding, crimping, soldering and/or an adhesive may also beoptionally used to secure the suture to the needle. FIG. 13B depictsanother example of a suture coupling section 1032, wherein the suture1034 is crimped or bonded to a sleeve 1036 of the suture couplingsection 1032. The suture 1034 within the sleeve 1036 may comprise asuture loop, or two ends of the same suture, or two or more ends of twoor more sutures. FIG. 13C depicts another embodiment wherein a singlesuture or line 1038 is attached to the sleeve 1036 of the suturecoupling section 1032. Although the sleeves 1036 in FIGS. 13B and 13Care closed ended with a single opening into which the sutures 1032, 1038are inserted, in other embodiments, the sleeves may have one or moreother openings. In some embodiments, the sutures may pass and/or beknotted through the additional openings.

In some embodiments, the suture or elongate member may be integrallyformed with the needle or penetrating member. In one example, thepenetrating member may comprise a stainless steel needle section whichtransitions, bifurcates or splits into one or more stainless steel wiresections have a greater flexibility or reduced rigidity than the needlesection. In another embodiment, depicted in FIG. 14, the distal section1040 may comprise the ends 1042 and 1044 of a polymeric or flexiblesuture 1046, but has been heat treated and/or adhesive bonded togetherand to stiffen the suture 1046. The distal section 1040 may be shaped toa tapered or beveled tip to function as a needle, or to facilitateinsertion of the distal section 1040 into a pre-formed opening orpassageway (e.g. by trocar or scalpel). In some embodiments, thepolymeric or flexible material may be interwoven or wound about one ormore metallic wires or cores to provide stiffening and penetrationcharacteristics. The distal section may also be covered or encapsulatedwith a sleeve or other type of structure.

The sutures used with various embodiments may have any of a variety ofsizes, configurations and materials. The sutures may have amonofilament, a multi-filament or braided configuration. Withmulti-filament or braided sutures, the individual filaments may have thesame or different sizes, configuration and materials. The suturematerial may comprise one or more absorbable and/or non-absorbablematerials, including but not limited plain or chromic catgut,poliglecaprone 25, polyglactin 910, polyglycolic acid, polydioxanone,silk, polyester, stainless steel, polypropylene and polyethylene, forexample. The suture diameter may range from about 0.0005 to about 0.04inches or more (or about size 10-0 to about size 7 per USP suture sizestandards), but in some embodiments, may be in the range of about 0.04to about 0.01 inches (or about size 5-0 to about size 2-0), and othertimes about 0.06 to about 0.08 inches (or about size 4-0 to about size3-0). Although the suture or pull member may have a generally circularcross-sectional shape, other suture shapes are also contemplated,including but not limited to flat or ribbon-type sutures. In still otherembodiments, a suture may be attached to a separately formed slingsection. In other embodiments, other flexible elongate structures may beused, including but not limited to chain structures. The suture or otherflexible elongate structure may be coated with one or more substances,including but not limited to anti-infective agents (e.g. triclosan) andfrictional or anti-frictional agents (e.g. collagen or PTFE,respectively).

In some embodiments, one or more portions of the suture 1400 may bedebraided or loosened to form a sling 1402 or other increased surfacearea section, as depicted in FIG. 14A. As depicted in FIG. 14B, thesling 1402 of the suture 1400 may facilitate the pulling of anorthopedic device 1404 by providing a more stable coupling through anincreased surface area and wider force distribution. The sling 1402 mayalso reduce the potential for damaging the surface of the orthopedicdevice 1404 from being sliced or cut by a narrower suture line. Thecoupling of the suture 1046 and the orthopedic device 1404 by wrappingor looping the suture 1400 around a portion of the orthopedic device1404, and other mechanisms for coupling the suture and orthopedicdevice, are described in greater detail below.

FIG. 15 depicts one embodiment of an orthopedic device 1500, comprisingan arcuate, “C”-shape body 1502 located between two ends 1504 and 1506.A suture coupling structure, comprising an aperture or lumen 1508through which a suture may be inserted, is provided through the body1502. In this particular embodiment, the lumen 1508 comprises a lumenaxis that is transverse to the plane of the “C”-shaped body 1502. Inother embodiments, the suture lumen may have any of a variety oforientations, and may lie within the plane of the “C”-shape body 1502,either aligned with the pull axis 1510, transverse to the pull axis1510, or any angle there between. The suture lumen may also be orientedin a skewed configuration with respect to the plane of the “C”-shapebody 1502. The suture lumen may also have any of a variety ofconfigurations, including but not limited to a linear configuration, acurved configuration, an angled configuration, a branching configurationwith multiple suture passageways, or any combination thereof. Also, thesuture lumen 1502 of the orthopedic device 1500 in FIG. 15 is providedat a midline 1512 of the body 1502, but in other embodiments, the suturelumen 1508 may be offset from the midline 1512. As shown in FIG. 15, theends 1504 and 1506 of the orthopedic device 1500 are symmetricallyconfigured with angular dimensions 1514 and 1516 of about 175 degreesfrom the suture lumen 1502, but in other embodiments, the ends 1504 and1506 may each be configured anywhere from about 0 degrees to about 180degrees (or more for spiral or other overlapping configurations). Forexample, with respect to a suture lumen or other reference point on theorthopedic device, each end may be configured about ±5, about ±10, about±15, about ±30, about ±45, about ±60, about ±75, about ±90, about ±105,about ±120, about ±135, about ±150, about ±165, about ±180, about ±185,about ±195, about ±210, about ±225, about ±240, about ±255, or about±270 degrees or more from the suture lumen or reference point. In someembodiments, the ends 1504 and 1506 may be asymmetrical or otherwiseconfigured differently. In some embodiments, more than one suture lumenmay be provided, and the configurations of the suture lumens may be thesame or different.

Referring to FIGS. 16A and 16B, in embodiments of the orthopedic device1600 comprising a core component 1602 and an articular component 1604,the suture lumen 1606 may be located along the lesser curvature 1608 ofthe orthopedic device 1600 with respect to the core component 1602. Insome embodiments, a suture lumen 1606 on the lesser curvature 1608 mayfacilitate the pulling of the orthopedic device 1600 into a joint orjoint capsule by pulling on the more rigid core component 1602 whichsupports the articular component 1604. This configuration of the suturelumen 1606 may also reduce the potential damage to the articularcomponent 1604 during pulling, by acting directly on the core component1602 rather than the articular component 1604. In other embodiments, asdepicted in FIGS. 16C and 16D, the suture lumen 1610 may be locatedalong the greater curvature 1612 of the orthopedic device 1600 withrespect to the core component 1602. Depending upon the particularmaterial and its structure, in some embodiments the articular component1604 may be stretched or deformed as the suture 1614 is pulling on theorthopedic device 1600. In still other embodiments, the suture lumen maypass above or below the core component on cross-sectional view.

The suture 1614 may be pre-threaded through the suture lumen 1606 and1610 of the orthopedic device 1600 at the point-of-manufacture, or maybe threaded at the point-of-use. The suture may also be pre-threaded orpre-attached to the needle, or may be separate from the needle. In someembodiments, the suture 1614 may be slidably threaded through the suturelumen 1606 and 1610, or may be non-slidable due to surface resistance,heat bonding, adhesives and other processes, for example. A needlethreader or other type of loop or threading tool may be provided aloneor in kit with the suture and/or orthopedic device to facilitatethreading. In embodiments comprising a suture lumen, the suture lumenmay be preformed or may be formed by a needle or other penetratingdevice used to pass the suture through the articular layer.

FIGS. 17A and 17B depict another embodiment of an orthopedic device 1630with an integrally formed suture 1632 or pull member positioned at afirst end 1634 of the orthopedic device 1630. In other embodiments, thesuture or pull member may comprise a suture loop coupled to a suturelumen located at an end of the device. The orthopedic device 1630 may bepulled into a joint space using the suture 1632 such that the deliveryprofile of the device 1630 into the joint is similar to the axialcross-sectional area of the device 1630. For example, once the suture1632 is passed through the joint and tensioned, the first end 1634 ofthe device 1630 is pulled into the joint, followed by the body 1636 andthen the second end 1638. As the device 1630 is pulled into the joint,the device 1630 may assume a straight or straighter configuration, butas a larger proportion of the device 1630 is pulled in, the bias orresilience of the device 1630 may assume a more bent configuration, asdepicted in FIG. 17B. Once positioned in the joint, all or at least aportion of the exposed suture 1643 may be separated or cut from theorthopedic device 1630.

As shown in FIGS. 18A and 18B, in some embodiments of the orthopedicdevice 1800, no suture lumen or other suture coupling structure isprovided. Instead, a loop of suture 1802 is looped around a portion ofthe orthopedic device 1800 to pull the orthopedic device into the joint.It is understood that this delivery method may also be utilized withorthopedic devices having suture lumens. Although a single loop isdepicted in FIGS. 18A and 18B, and two or more loops may be made aroundthe body of the orthopedic device 1800. In some embodiments, the suture1802 is looped away from either end 1804 and 1806 of the orthopedicdevice 1800, but not necessarily about a midline of the body orsymmetrically between the two ends 1804 and 1806. After the orthopedicdevice 1800 is pulled into position, one end (not shown) of the suture1802 may be released and the suture may be pulled off or away from theorthopedic device 1800. In some embodiments, the suture may also beknotted or tied to the orthopedic device 1800, and a portion of thesuture may remain attached to the orthopedic device 1800 followingimplantation. In other embodiments, the suture may be separated from theorthopedic device by passing the suture 1802 out of the gap 1808 betweenthe two ends 1804 and 1806. In other embodiments, a tether (not shown)may be provided across the two ends 1804 and 1806 to resist inadvertentpassage of the suture 1802 through the gap 1808. The tether may beprovided with a laxity or redundant length, which may permit additionalseparation of the two ends 1804 and 1806, in addition to permitting thetwo ends 1804 and 1806 to come closer together or overlap. In stillother embodiments, the length of the tether may be configured to controlthe degree of separation, overlap or crossing between the two ends 1804and 1806, and in some embodiments, may even be tensioned or taut in itsnative configuration. The tether may comprise an elastic or inelasticmaterial or structure. Multiple tethers or bridge structures may beprovided across the gap, if any, of the orthopedic device.

In another embodiment, a suture coupling structure 1900 may extend orotherwise be located external to the outer surface of the articularlayer 1902 of the orthopedic device 1904. In FIGS. 19A and 19B, forexample, the suture coupling structure comprises an eyelet 1900 locatedabout the greater curvature 1906 of the orthopedic device 1904. Asshown, the aperture 1908 of the eyelet 1900 has a through axis that istransverse to the plane of the “C”-shape orthopedic device 1904, but inother embodiments, any other orientation may be used. Although eyelet1900 has a general circular configurations, other configurations arealso contemplated, including but not limited oval, square, triangular orother polygonal or curvilinear shapes. The cross-sectional shape of theaperture may or may not have a similar general shape as the suturecoupling structure. In other embodiments, the suture coupling structuremay comprise a flange, T-bar, hook or other coupling structure. In somefurther embodiments, the suture coupling structure may be partially orcompletely recessed with respect to the outer surface of the articularlayer. The suture coupling structure may comprise any of a variety ofmaterials, including but not limited to a metal, plastic, or combinationthereof. The material may be the same or different from one or moreother components of the orthopedic device. As noted in FIG. 19A, theeyelet 1900 is generally located along the midline that generally splitsthe orthopedic device body 1910 and/or orthopedic device ends 1912 and1914 in half, but in other embodiments, may be located on an end 1912and 1914 of the orthopedic device 1904 or anywhere there between. Forexample, the eyelet 1900 may be located approximately at the 180 degreeposition as depicted in FIG. 19A, but may have other locations dependingupon the particular orthopedic device configuration, including but notlimited to about the 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165,195, 210, 225, 240, 255, 270, 285, 300, 315, 330, and 345 degreepositions on a superior elevational view of the orthopedic device. Asnoted in FIG. 19B, the circumferential location of the eyelet 1900 maybe located midway between the upper and lower portions of the orthopedicdevice along the greater curvature 1906 at the 180 degree position, butin other embodiments may be located on the lesser curvature 1916 oranywhere between the greater curvature 1906 and the lesser curvature1916, including but not limited to about the 0, 15, 30, 45, 60, 75, 90,105, 120, 135, 150, 165, 195, 210, 225, 240, 255, 270, 285, 300, 315,330, and 345 degree positions on an axial cross-sectional view. Theeyelet 1900 may also have a general orientation that is perpendicular(i.e. 90 degrees) to the outer surface of the articular layer, but insome embodiments, the angle may be anywhere from about −45 to about +135degrees, including but not limited to −30, −15, 0, +15, +30, +45, +60,+75, +105, and +120 degrees. The eyelet 1900 of FIG. 19A is shown in agenerally flush position with respect to the outer surface of thearticular layer, in other embodiments, the eyelet 1900 may have aflexible or rigid stem, stalk or tether with a length of about to about5 mm or more, and sometimes about 2 to about 4 mm, or more. Asillustrated in FIG. 19A, the orthopedic device 1904 further comprises acore component 1918 with enlarged or bulbous ends 1920. In someembodiments, the enlarged ends 1920 of the core component 1918 mayreduce the risk that the ends 1920 make poke or protrude from thearticular layer. The eyelet 1900 may be attached to the articular layer1902 and/or the core component 1918, and at least a portion of theeyelet aperture, if not all of the eyelet aperture, may be external tothe articular layer. In other embodiments, as described below, theeyelet aperture may be embedded within the articular layer.

FIG. 19C depicts another embodiment of an orthopedic device 1930,comprising an eyelet 1932 located inline along the length of the coremember 1934. An inline eyelet may or may not be covered by the articularlayer 1936 of the orthopedic device 1930. FIG. 19D depicts anotherembodiment of an orthopedic device 1938, comprising an eyelet 1940offset from the core member 1942 and covered by the articular layer1944. In this embodiment, the articular layer 1944 maintains its generalsurface curvature about the eyelet 1940, but in other embodiments, theregion of the articular layer overlying the eyelet may be thicker orthinner along the superior, inferior, outer, and/or inner eyeletsurface. The eyelet 1940 in FIG. 19D is generally located midway aboutthe greater curvature of the orthopedic device 1938, but in otherembodiments, may be located anywhere along the length of the orthopedicdevice, including the lesser curvature or closer to one of the ends ofthe orthopedic device. In still other embodiments, such as theembodiment illustrated in FIG. 19E, the orthopedic device 1946 may lackan eyelet or other reinforcement structure, but the articular layer 1948about the suture opening 1950 may have one or more increased dimensionsto resist rupture of the articular layer 1948 by the suture or pullmember during implantation. In some of the embodiments, the eyelet maybe formed by twisting a loop from the core member.

In some embodiments, the suture may comprise a complementary interfitstructure that releasably locks with the coupling structure. Forexample, the suture may comprise a hook or a latch that may bereleasably attached to an eyelet coupling structure of the orthopedicdevice. Also, in some embodiments, the suture coupling structure may beconfigured with a pre-selected location with respect to the orthopedicdevice, but in other embodiments, the location may be user-selected. Forexample, the suture coupling structure may comprise a slidable eyeletthat may be repositioned with respect to the orthopedic device, or asuture coupling structure that may be attached to the orthopedic deviceat the point-of-use by one or more barbs, books, clamps and the like.The suture coupling structure may be configured to attach to thearticular component and/or the core component of the orthopedic device.In some embodiments, more than one suture coupling structure may beprovided.

As described for the embodiment illustrated in FIG. 16B, the suturelumen 1606 may be located so that the suture 1614 can contact andpotentially act directly on the core 1602. As shown in FIG. 16B,however, when the pulling force from manipulating the suture 1614 isapplied, portions of the articular layer 1604 may still experience highstresses where the suture 1516 exits the suture lumen 1606 at its lumenopenings 1616 and 1618. In contrast, FIGS. 20A and 20B depicts anembodiment of an orthopedic device 2000 comprises a segmented articularlayer 2002 and 2004 with a core component 2006 having an exposed region2008 where a suture 2010 may be looped around the core component 2006without necessarily exerting any force on any portion of the articularlayer 2002 or 2004. In some embodiments, the exposed region 2008 of thecore component 2006 may have a different surface treatment or coatingthan the other portions that are covered by the articular layer.

FIGS. 21A and 21B depict another embodiment of an orthopedic device2100, comprising a suture or tether 2102 that has been integrally formedwith the orthopedic device 2100. The tether 2100 may be bonded to thesurface and/or the internal structure of the articular layer 2104,and/or optionally bonded or formed with the core component 2106 of theprosthesis 2100. In some embodiments, the tether 2102 may be heat bondedor glued to the orthopedic device, embedded within the orthopedicdevice, and/or extruded from the orthopedic device (e.g. wherein thetether 2102 comprises a flowable material that is similar to thematerial comprising the articular layer 2104 or core component 2106).

Although several embodiments described herein may comprise or may beimplanted using a single needle or suture, in some embodiments, two ormore sutures and/or needles may be used to implant the orthopedicdevice. In FIG. 22A, for example, the orthopedic device 2200 may beattached to two sutures 2202 and 2204 during the implantation procedure.The two sutures 2202 and 2204 may be attached or threaded to the sameneedle or to different needles. In some embodiments, the use of twosutures may facilitate the implantation of an orthopedic device that isimplanted in an alternate fashion, e.g. where the ends 2206 and 2208 ofthe orthopedic device 2200 are inserted into the joint space first, orwhere the inner curvature 2210 of the orthopedic device will be loopedaround an intra-articular structure (e.g. the anterior or posteriorcruciate ligament of a knee joint), and the ends 2206 and 2208 of theorthopedic device 2200 are spread apart. Although the suture lumens 2212and 2214 of the orthopedic device 2200 are symmetrically located on eachend 2206 and 2208 of the orthopedic device 2200, each suture lumen 2212and 2214, may be located any where along the length of the orthopedicdevice and the configurations each suture lumen may be the same ordifferent. In some examples, orthopedic devices attached to multiplesutures, such as the sutures 2202 and 2204 attached to the orthopedicdevice 2200, may also be cinched and/or tied together to adjust theconfiguration of the orthopedic device and/or to form a closed-loopdevice. In still other embodiments, one or more sutures may beintegrally formed with the orthopedic device, rather than being loopedthrough a suture lumen or looped around the body of the orthopedicdevice.

In some embodiments, different suture types may be used during animplantation procedure. For example, in FIG. 22B the orthopedic device2300 is attached to three sutures 2302, 2304 and 2306, wherein onesuture 2302 is larger than the other sutures 2304 and 2306. In theillustrated embodiment, the larger sutures 2302 may be used to pull theorthopedic device, for example, through a percutaneous pathway, throughone or more joint capsules, and sometimes even through one or moreligaments or other connective tissue structure about the affected joint.The larger suture 2302 may tolerate higher pulling forces than one ormore of the other sutures 2304 and 2306. In some embodiments, the othersutures 2304 and 2306 may be to reorient the orthopedic device 2300 toits desired position and need not have a greater thickness.

FIG. 23A illustrates another embodiment of an orthopedic device 2310with at least one suture or pull member 2312 coupled to a first distalregion 2314 of the orthopedic device 2310, wherein the pull member 2312is further slidably or movable coupled to a first proximal region 2316of the orthopedic device 2310. In this particular embodiment, the pullmember 2312 may be used to adjust the relative position of the firstdistal region 2314 (e.g. end region) with respect to the first proximalregion 2316 (e.g. midline region). As shown in FIG. 23A, multiplediscrete pull members 2312 and 2318 may be provided, and each may beattached to different distal regions 2314 and 2320, or a branched orinterconnected pull member may be provided. Discrete multiple pullmembers 2312 and 2318 may permit independent adjustment or manipulationof the distal regions 2314 and 2320. The pull members 2312 and 2318 maybe coupled to the same proximal region 2316 or to different proximalregions. The distal regions 2314 and 2320 in FIG. 23B are depicted asbeing folded inward into the central opening 2322 of the orthopedicdevice 2310, but in other embodiments, the pull members 2312 and 2318may be manipulated to a lesser degree, e.g. to adjust the relative gapspacing between the regions 2314 and 2320 without infolding into thecentral opening 2322. Although not depicted in FIGS. 23A and 23B, theorthopedic device 2310 may further comprise a third pull member loopedor coupled to the first proximal region 2316, which may be used to pullon the orthopedic device 2310 without pulling on the distal regions 2314and 2320.

In some embodiments, orthopedic devices with multiple pull members maybe used, for example, to restrict the range of configurational change ofthe orthopedic device. In FIGS. 23C and 23D, for example, the orthopedicdevice 2330 may comprise pull members 2332 and 2334 attached to distalregions 2336 and 2338 passing through one or more proximal regions 2340.Rather than separating or severing the pull members 2332 and 2334 fromthe distal regions 2336 and 2338, once the orthopedic device 2330 ispositioned, one or more pull members 2332 and 2334 may be attached toeach other or further attached to the orthopedic device 2330 to limit orrestrict separation of distal regions 2336 and 2338 from the proximalregion(s) 2340. In FIG. 23D, for example, the proximal region 2340comprises a post 2342 or other interference structure. When the pullmembers 2332 and 2334 are fixedly coupled to each other (e.g. with knot2344 or other coupling procedure or mechanism), the post 2342 restrictsor limits the distance by which the distal regions 2336 and 2338 mayseparate from the proximal region 2340. In this specific embodiment,some relative sliding the knotted pull members 2332 and 2334 may occurwith respect to the post 2342, which may permit some separation of thedistal regions 2336 and 2338, but in other embodiments, the pull members2332 and 2334 may be directly knotted to the post 2342 or interferencestructure to restrict or limit sliding or other movement of the pullmembers 2332 and 2334.

FIGS. 23E and 23F depict another embodiment of an orthopedic device 2350comprising multiple pull members 2352 and 2354 distally coupled tomultiple distal regions 2356 and 2358 and proximally passing through aproximal region 2360. An interference member 2362 may be positioned withrespect to the proximal region 2360 to restrict sliding or movement ofthe pull members 2352 and 2354. In the particular embodiment depicted inFIGS. 23E and 23F, the interference member 2362 comprises a plugstructure which may be configured to form a friction and/or mechanicalinterfit with the through opening of the proximal region 2360 and/or thepull members 2352 and 2354. In other embodiments, the interferencemember 2362 may comprise a clip, clamp, or crimp member, for example.

As previously described, in some embodiments, the needle used to insertthe suture through the joint capsule and joint space may be manipulatedmanually by hand or with a pair of needle forceps. In some embodiments,longer and larger needles may be used when manipulating by hand, and/orwhen the orthopedic device implantation procedure is performedpercutaneously through thicker dermal and connective tissue layers. Inother embodiments, however, shorter needles may be used. FIG. 24, forexample, depicts one embodiment of a short needle 2400 connected to ashort suture loop 2402 that is looped through a small orthopedic device2404 that is configured for a DIP, PIP, MP or CMC joint. These joints ofthe hand and wrist may involve minimal skin and underlying connectivetissue penetration during percutaneous access, even in obese patients.Although the suture knot 2406 of the suture loop 2402 is schematicallydepicted between the needle eyelet 2408 and the suture lumen 2410 of theorthopedic device 2404, in practice, the knot 2406 may be positioned ator adjacent to the needle eyelet 2408, or buried within the suture lumen2410.

Referring to FIGS. 25A and 25B, in some embodiments, to facilitate themanipulation and use of needles during the implantation procedure, aneedle driver 2500 may be provided. In some embodiments, the needledriver 2500 may permit improved control and/or force applicationcompared to pair of needle forceps, as the driver shaft 2502 of thedriver 2500 may be aligned with the direction of force application. Incontrast, a needle held by a pair of needle forceps is often orientedtransversely or skewed with respect to the clamp members of the forceps,and therefore lacks the direct force transfer and stability of a needledriver as depicted in FIG. 25A. As illustrated, the needle driver 2500may comprise a proximal handle 2504 from which the driver shaft 2502distally extends. The distal end 2506 of the driver shaft 2502 comprisesa longitudinal lumen 2508 which is configured to regain the proximal endof a needle, such as the suture coupling section 2412 of the needle 2400depicted in FIG. 24. The lumen 2508 is typically configured to retain atleast a portion the suture 2402 attached to the needle 2400. The lumen2508 may comprise one or more optional side slots 2510 or openings topermit the suture 2402 to emerge from the driver shaft 2502. In someembodiments, the side slot(s) 2510 may permit the walls of the lumen2508 to expand outward, particularly for but not limited to when theneedle 2400 is inserted into the lumen 2508. In embodiments where thelumen 2508 is expandably configured to retain the proximal end of theneedle 2400 and suture 2402, frictional resistance from the compressiveforces acting on the needle may further facilitate retention of theneedle 2400 by the needle driver 2500. In other embodiments, areleasable clamp, retaining pin assembly or other active holdingmechanism may be provided on the needle driver to releasably hold theneedle 2400.

FIG. 26 depicts the needle driver 2500 of FIG. 25 with the needle 2400of FIG. 24 inserted into its lumen and with the suture loop 2402 locatedin the side slot 2510. As depicted, the suture loop 2402 and theorthopedic device 2404 are not attached to the driver 2500 and arefreely mobile. In some embodiments, in use, the suture loop 2402 and theorthopedic device 2404 may dangle from the driver 2500, or may be heldin place by the surgeon in the same hand used to hold and manipulate thedriver 2500.

FIG. 27 depicts the needle driver 2500 of FIG. 25 loaded with the needle2400 of FIG. 24, but with a longer suture loop 2700 attaching theorthopedic device 2404 and the needle 2400. As shown in FIG. 27, thelonger suture loop 2700 may be wrapped along the length of the drivershaft 2502 to retain at least some loose length of suture loop 2700.Depending on the manner with which the suture loop 2700 is wrapped, theextent with which the orthopedic device 2404 may dangle or hang duringthe procedure may also be reduced. In use, the needle driver 2500 withloaded needle 2400 is inserted through the affected joint until theneedle 2400 is accessible on the opposite side of the joint. In oneembodiment, the needle driver 2500 may be held in place as the needle2400 is pulled out of the body. As the needle 2400 is pulled, the coiledsuture loop 2700 may be unraveled and may be pulled out along with theneedle 2500. In some embodiments, once the needle 2400 is accessible onthe opposite side of the joint, the needle driver 2500 may be withdrawn,leaving an unsupported coil of the suture loop 2700 in the patient,which is then pulled out using the needle 2400 or portion of the sutureloop 2700 connected to the needle 2400.

In other embodiments, the needle driver may include one or more otherretaining structures to releasably hold the suture loop and/or theorthopedic device during the implantation procedure. The retainingstructures may include but are not limited to hooks, clamps, clips,latches, posts, slots, recesses, cavities and other structures which maybe used to retain one or more portion of the suture loop and/or theorthopedic device. In FIGS. 28A and 28B, for example, the “C”-shapeorthopedic device 2404 may be resiliently and releasably clipped to apost or drum 2800 located on the driver shaft 2802 of the needle driver2804. In this particular embodiment, the drum 2800 further comprises aflange 2806 that may resist slippage of the orthopedic device 2404 offof the drum 2800. As shown in FIG. 28A, the drum 2800 may be positionedon the driver shaft 2802 in generally circumferential alignment with theslot 2810 of the driver shaft 2800. In some embodiments, this alignmentmay facilitate the release of the orthopedic device 2404 from the drum2800 by providing a direct pulling vector along the suture loop 2402from the needle 2400 to the orthopedic device 2404. In otherembodiments, the drum 2800 may be located out of alignment with respectto the slot 2810 of the driver shaft 2800, and/or one or more coils ofsuture loop 2402 may be wound onto the driver shaft 2500. FIG. 29, forexample, depicts the needle driver 2804 of FIG. 28A is loaded with theneedle 2400, orthopedic device 2404 and suture loop 2700 from FIG. 27,where the excess portions of the suture loop 2700 have been releasablycoiled onto itself and the driver shaft 2802 of the needle driver 2804.

FIGS. 30A to 32B illustrate one embodiment of an implantation methodinvolving an orthopedic device 2900 and a needle driver 2902. The joint2904 depicted in FIGS. 30A to 32B is a schematic representation of ametacarpal-phalangeal (MCP) joint 2904 formed between a proximal phalanxPh and its associated metacarpal MC and enclosed by a joint capsule JC,but in other embodiments, may be schematically illustrative of a varietyof joints that may be treated in a medical or veterinary setting. Insome embodiments, the orthopedic device 2900 may be inserted on anout-patient basis using only local or regional anesthesia, but in otherembodiments, general anesthesia may be used. Depending upon whether thevarious components of the procedure are provided in pre-attached form ornot, the needle 2906, suture 2908 and orthopedic device 2900 may beattached as needed and loaded into the needle driver 2902. In someembodiments, the orthopedic device 2900 may be provided in sealed,pre-hydrated packaging, but in other embodiments, the orthopedic device2900 may be soaked in a saline or other type of liquid for about 5minutes to about 15 or about 30 minutes before being coupled to thesuture 2908 and/or needle 2906, if not already coupled or pre-coupled.The patient's affected hand is prepped and draped in the usual sterilefashion. The MCP joint is identified on the dorsal and palmar (or otherproximal and distal) surfaces of the affected region, with or withoutfinger flexion or traction. A dorsal transverse incision is made acrossthe joint. In some embodiments, the incision is made using a scalpel,but in other embodiments, the penetrating tip of the needle driver 2902may comprise a spatula or spade cutting tip, which may be oriented toachieve a transverse incision. In some alternate embodiments, alongitudinal incision or stab incision may be used instead, and/or theincision may be initiated on the palmar side of the MCP joint, or fromthe lateral or medial aspect of the MCP joint, taking care not to injureany of the digital nerves of the fingers. The connective tissue isoptionally dissected if desired until the joint capsule of the MCP jointis identified.

As shown in FIGS. 30A and 30B, the loaded needle driver 2902 may beinserted through the joint capsule JC. The needle driver 2902 may bedirected across the joint space 2912 until the opposing side of thejoint capsule JC is penetrated and the needle 2906 may be accessed.Referring to FIGS. 31A and 31B, forceps or other type of graspinginstrument may be used to engage the protruding needle 2906 and isfurther pulled out and/or away from the joint 2904. The needle driver2902 may be braced or stabilized as the suture 2908 is tensioned andbegins to pull the orthopedic device 2900. The orthopedic device 2900may be pulled away from the retaining post 2914 of the driver shaft2916, through the joint capsule JC and into the joint space 2912.Depending upon the method used to achieve joint access, the orthopedicdevice 2900 may collapse or pinch inward as the orthopedic device passesthrough the joint capsule JC and then expands as the orthopedic device2900 emerges from joint capsule JC and into the joint space 2912. Theseating or positioning of the orthopedic device 2900 in the joint spacemay be checked by tactile response to tensioning the suture 2908 and/orby fluoroscopy or arthroscopy, for example. Once the desired positioningof the orthopedic device 2900 is confirmed, the joint range of motionmay be checked, along with joint loading to check for joint crepitus orlocking. As depicted in FIGS. 32A and 32B, one or both suture lines 2908exposed on the palmar side of the joint may be cut or severed and thenpulled out to separate from the orthopedic device. In some embodiments,closure of the initial incision is not required due to the small size ofthe incision, but in other embodiments, about one to about three smallstitches may be applied using 4-0 or 5-0 non-resorbable sutures, forexample, to close the incision. The skin incision, if any, may be closedusing sutures, staples or tissue adhesives. The range of motion isoptionally rechecked again, and the incision may then be dressed orsplinted as determined by the surgeon.

It will be understood that the foregoing is only illustrative of theprinciples of the invention, and that various modifications,alterations, and combinations can be made by those skilled in the artwithout departing from the scope and spirit of the invention. Any of theembodiments of the various orthopedic devices disclosed herein caninclude features described by any other orthopedic devices orcombination of orthopedic devices herein. Furthermore, any of theembodiment of the various orthopedic device delivery and/or retrievalsystems can be used with any of the orthopedic devices disclosed, andcan include features described by any other orthopedic device deliveryand/or retrieval systems or combination of orthopedic device deliveryand/or retrieval systems herein. Accordingly, it is not intended thatthe invention be limited, except as by the appended claims. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

1. An orthopedic device system, comprising: a free-floating orthopedicdevice comprising separate first and second resilient elongate cores,and a flexible bi-concave polymeric jacket comprising a C-shapedperimeter member surrounding a central span member and covering thefirst and second resilient elongate cores, the jacket comprising a notchlocated between two ends of the C-shaped member, the notch intersecting:a) a top concave surface of the polymeric jacket and facing a firstdirection; b) a bottom concave surface facing a second directionopposite the first direction; and c) a side perimeter surfacetherebetween; wherein the orthopedic device is configured to residebetween two opposing articular surfaces and within a joint space of ajoint.
 2. The orthopedic device system of claim 1, wherein the firstelongate core has a delivery configuration and an implantationconfiguration.
 3. The orthopedic device system of claim 2, wherein theimplantation configuration is a non-linear configuration.
 4. Theorthopedic device system of claim 2, wherein the delivery configurationis a linear configuration.
 5. The orthopedic device system of claim 1,further comprising a suture.
 6. The orthopedic device system of claim 5,wherein the suture is located in a first suture aperture.
 7. Theorthopedic device system of claim 5, further comprising a needle member.8. The orthopedic device system of claim 7, wherein the needle member ispre-attached to the suture and configured to pull the orthopedic deviceinto the joint space.
 9. The orthopedic device system of claim 7,wherein the needle member, the suture and the orthopedic device areprovided in a single sterile package.
 10. The orthopedic device systemof claim 7, further comprising a needle member holder.
 11. Theorthopedic device system of claim 10, wherein the needle member holdercomprises an orthopedic device retaining assembly.
 12. The orthopedicdevice system of claim 1, wherein the joint space is a joint space of ahand, wrist, shoulder, foot or ankle joint.